Health Science International, Inc.

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IN THE MATTER OF HEALTH SCIENCE INTERNATIONAL, INC., AND DAVID MARTIN CONSENT ORDER, ETC., IN REGARD TO ALLEGED VIOLATIONS OF SEC. 5 AND SEC. 12 OF THE FEDERAL TRADE COMMISSION ACT Docket C-4205; File No. 072 3145 Complaint, November 13, 2007 – Decision, November 13, 2007 This consent order relates to the deceptive advertising and promotion of respondents’ transdermal cream, Serenity for Women Natural Progesterone Cream. The complaint alleged that respondents violated the FTC Act by falsely advertising that its cream was effective (a) in preventing, treating, or curing osteoporosis; (b) in preventing or reducing the risk of estrogen-inducted endometrial (uterine) cancer; and (c) in reducing or alleviating the user’s risk of developing breast cancer. The complaint alleged that respondents had no substantiation for these claims. The consent order requires that respondents have competent and reliable scientific evidence substantiating claims that any progesterone product or any other dietary supplement, food, drug, device or health-related service or program is effective in preventing, treating, or curing any disease. The order further bars respondents from engaging in similar acts and practices in the future and prohibits respondents from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. Participants For the Commission: Gregory A. Ashe, Laura DeMartino, Janice P. Frankle, James A. Kohm, and Michael Ostheimer. For the Respondents: Not represented by counsel. COMPLAINT The Federal Trade Commission, having reason to believe that Health Science International, Inc., a corporation, and David Martin, individually and as an officer of Health Science International, Inc. (“Respondents”), have violated the provisions of the Federal Trade VOLUME 144 Complaint Commission Act, and it appearing to the Commission that this proceeding is in the public interest, alleges: 1. Respondent Health Science International, Inc. is a Florida corporation with its principal office or place of business at 1648 Taylor Road, Suite 118, Port Orange, Florida 32128. 2. Respondent David Martin is an officer of Health Science International, Inc. Individually, or in concert with others, he formulates, directs, controls, or participates in the policies, acts, or practices of Health Science International, Inc., including the acts and practices alleged in this complaint. His principal office or place of business is the same as that of Health Science International, Inc. 3. The acts and practices of Respondents alleged in this complaint have been in or affecting commerce, as “commerce” is defined in Section 4 of the Federal Trade Commission Act. 4. Many women experience symptoms of menopause including hot flashes (also called flushes), night sweats, sleep disturbances, and painful intercourse. To relieve the symptoms of menopause, some doctors prescribe hormone therapy. This typically involves the use of either estrogen alone (for women who have had a hysterectomy) or (for women who have not had a hysterectomy) estrogen with an orally administered progestagen. Progestagen is a general term that includes progesterone (which is the progestagen produced by the human body or which can be synthesized as a drug) and progestins (which are synthetic forms of progestagens). A progestagen is added to estrogen to prevent hyperplasia (cell overgrowth) in the endometrium (lining of the uterus). This overgrowth can lead to endometrial (uterine) cancer. While progestagens decrease a woman’s risk of estrogen-induced endometrial cancer, progestins have been found to increase a woman’s risk of developing breast cancer. HEALTH SCIENCE INTERNATIONAL, INC. 1035 Complaint 5. Respondents have advertised, offered for sale, sold, and distributed products to the public throughout the United States, including Serenity for Women Natural Progesterone Cream. Respondents advertise and offer the products for sale through the Internet sites www.health-science.com and www.progesterone .com. 6. For the purposes of Section 12 of the FTC Act, 15 U.S.C. § 52, Serenity for Women Natural Progesterone Cream is a “drug” as defined in Section 15(c) of the FTC Act, 15 U.S.C. § 55(c). 7. Serenity for Women Natural Progesterone Cream is a drug labeled as containing Natural Progesterone USP (2.25%) and other ingredients. A 60 gram jar costs $32 plus shipping and handling. Serenity for Women Natural Progesterone Cream is applied transdermally.

8. To induce consumers to purchase Serenity for Women Natural Progesterone Cream, Respondents have disseminated or have caused to be disseminated advertisements, including but not necessarily limited to the attached Exhibit A. These advertisements contain the following statements and depictions, among others, on Respondents’ website:

A. Does Progesterone or Estrogen increase or decrease my risk for cancer? Molecular biologist, Dr. Ben Formby of Copenhagen, Denmark and Dr. T.S. Wiley at the University of California in Santa Barbara have researched two genes, BCL2 and P53, and their effect on female-specific cancers and prostate cancer.

Cells of breast, endometrium, ovary and prostate, were grown in the laboratory. Estrogen (estradiol) was added to the cells. This hormone turned on the BCL2 gene, causing the cells to grow rapidly and not die. Then, progesterone VOLUME 144 Complaint was added to the cell cultures. Cell reproduction stopped and the cells died on time (apoptosis).

This methodology was applied to all the above types of cancer. The BCL2 gene, therefore, stimulates the growth of these cells and the risk of cancer. On the other hand, the P53 gene promotes apoptosis or programmed cell death and thereby, reduces the risk of cancer. Estradiol upregulates or stimulates the production of the BCL2 gene, while progesterone upregulates or stimulates the production of the P53 gene.

Therefore natural progesterone decreases the risk for several types of cancer, while unopposed estradiol causes these same types of cancer. Since Breast cancer is considered to be a hormone dependent cancer it is critically important to maintain optimal levels of natural progesterone and avoid the factors that would promote too much estradiol.

* * * Clearly the underlying causes of breast cancer are too much estrogen relative to too little natural progesterone, especially in the presence of trans fatty acids (hydrogenated fats).

“When faced with decisions on critically important health issues such as breast cancer, ovarian cancer, endometriosis, fibrocystic breast disease, migraine headaches, infertility & osteoporosis, Informed Women demand and deserve the finest natural progesterone cream formula available anywhere in the world “Serenity for Women Certified Potency Progesterone Cream.” (Exhibit A at 2.) HEALTH SCIENCE INTERNATIONAL, INC. 1037 Complaint B. Natural progesterone is remarkably safe and free of sideeffects when administered in a proper cream formulation. (Exhibit A at 4.) C. Because the female body uses natural progesterone to make natural estrogen, a properly formulated natural progesterone cream is the natural safe choice for menstruating women and for post-menopausal women seeking to establish the correct balance of their two primary female hormones.

This balance of Natural Progesterone and Natural Estrogens will protect them from the effects of the condition known as “Estrogen Dominance”.* The resultant Benefits of natural progesterone include * * * Helps Protect Epithelial cells against Breast Cancer Helps Prevent Endometrial Cancer Helps prevent Ovarian Cysts and Ovarian Cancer * * * Stimulates Osteoblast Cells (Osteoporosis Reversal) As you can see, natural progesterone counterbalances the effects of too much estrogen discussed here. (Exhibit A at 5.) D. Bone tissue should be broken down and rebuilt continuously, just like all of the cells in our body. This process takes place when Osteoclasts help to dissolve old bone tissue, while osteoblasts stimulate new bone growth. Because estrogen has a rate limiting effect on Osteoclasts, VOLUME 144 Complaint Estrogen Dominance delays the breakdown of bone tissue but does not support bone building (osteoblast function). Natural progesterone, on the other hand, stimulates osteoblast production which results in new bone tissue growth. Consequently, estrogens only slow down bone loss, not promote the formation of new bone tissue. Osteoporosis Research The efficacy of natural progesterone is verified by a three year study of 63 post-menopausal women with osteoporosis.** Women using transdermal progesterone cream experienced an average 7-8% bone mass density increase the first year, 4-5% the second year and 3-4% the third year! Untreated women in this age category typically lose 0.7% to 2.0% bone mineral density per year!!! These results have not been found with any other form of hormone replacement therapy, prescription medication or dietary supplement! Conclusion Maintaining proper levels of natural progesterone, giving due attention to dietary choices, dietary calcium, managing stress and regular exercise are all vital components of strong, healthy bones.

(Exhibit A at 6.) E. Side Effects: There are no reports of any significant side effects or health problems associated with natural progesterone.

(Exhibit A at 8.) HEALTH SCIENCE INTERNATIONAL, INC. 1039 Complaint F. Dear Health & Science I am 54 and have been using Serenity for Women for over 3 years now.

Recently, I had my first bone density test. I was very scared because I had a number of risk factors for osteoporosis. The results of my test? Bones of a 25 year old! My Doctor had never seen such a high rating for someone my age.

I am amazed! (Exhibit A at 10.) G. Because estrogen has a rate limiting effect on Osteoclasts, Estrogen Dominance delays the breakdown of bone tissue but does not support bone building (osteoblast function). Natural progesterone, on the other hand, stimulates osteoblast bone cell activity which results in new bone tissue growth. Consequently, estrogens only slow down bone loss, not promote the formation of new bone tissue. Osteoporosis Research The efficacy of natural progesterone is verified by a three year study of 63 post-menopausal women with osteoporosis. ** Women using transdermal progesterone cream experienced an average 7-8% bone mass density increase the first year, 4-5% the second year and 3-4% the third year! Untreated women in this age category typically lose 0.7% to 2.0% bone mineral density per year!!! These results have not been found with any other form of hormone replacement therapy or dietary supplementation!... VOLUME 144 Complaint Vital, necessary factors for the maintenance of strong, healthy bones are:

$ Maintaining proper levels of natural progesterone; * * * (Exhibit A at 11-12.) H. It is also important that we distinguish Natural Progesterone from Yam extract and from its counterparts in the drug industry - PROGESTINS. Although these drugs are commonly referred to as progesterone, this is a misnomer. In some ways they mimic the effects of progesterone in the body, but in other important ways they gravely interfere with natural progesterone and can create and exacerbate hormone related health problems, and be a primary contributor to the condition referred to as Estrogen Dominance:

* * * Increased Risk of Breast Cancer * * * Increased Risk of Endometrial Cancer Increased Risk of Uterine Cancer * * * When the above list of ill-effects is compared to the benefits of Natural Progesterone, we see a nearly one-toone correlation.

(Exhibit A at 13.) I. Dr. John Lee, of California, U.S.A., used natural progesterone creams in his practice for 19 years. He states HEALTH SCIENCE INTERNATIONAL, INC. 1041 Complaint in his books that natural progesterone is remarkably safe and free of side-effects when administered in a proper cream formulation.

(Exhibit A at 15.) J. The more natural method of raising progesterone levels is free from side-effects. This has been well documented by the high rate of success reported by Dr. John R. Lee, M.D., using Transdermal Natural Progesterone in his practice for approximately 19 years and the success reported to the Health & Science Research Institute from thousands of women around the world.

Finally, oral progesterone will produce a sharp rise in serum progesterone levels followed by a rapid drop within about an hour. Progesterone administered via a properly formulated progesterone cream will raise systemic progesterone levels for eleven or twelve hours. This offers informed women continual and stable progesterone levels which may play a critical role in the prevention of female specific cancers, the amelioration of the symptoms of PMS & Menopause, the ability to get and stay pregnant, and the reversal of Osteoporosis. (Bone loss in women who live in industrialized countries begins, on average, at age 35). In thirty years of clinical practice, seventeen recommending transdermal natural progesterone, Dr. Lee has observed the consistent benefits and safety of natural progesterone therapy.

(Exhibit A at 19.) K. Natural Transdermal Progesterone Cream, applied topically to the face, neck, arms, chest and fatty tissue areas of the body such as the breasts, the abdominal area, the buttocks, the inner thighs, etc., is stored in these fatty tissues for use as required by the body and has been shown to reverse the effects of Estrogen Dominance listed below: VOLUME 144 Complaint * * * Increased Risk of Breast Cancer Increased Risk of Ovarian Cancer Increased Risk of Endometrial Cancer Restraint of Osteoclast Function (bone loss) * * * It is also important that we distinguish Natural Progesterone from its counterparts in the drug industry - PROGESTINS. Although these drugs are commonly referred to as Progesterone, this is a misnomer. In some ways they mimic the effects of Natural Progesterone in the body, but in other important ways they gravely interfere with Natural Progesterone and can create and exacerbate hormone related health problems, and be a primary contributor to Estrogen Dominance. (Exhibit A at 20.) L. Serenity for Women has been carefully formulated for women who suffer with the unpleasant symptoms of Menopause & PMS, and who are experiencing the conditions of Infertility and Osteoporosis. (Exhibit A at 23.) M. When faced with decisions on critically important issues such as breast cancer, ovarian cancer, endometriosis, fibrocystic breast disease, migraine headaches, infertility and osteoporosis, informed women demand and deserve the finest cream available anywhere in the world. Serenity for Women, Certified Potency, Natural Progesterone Cream (Exhibit A at 24.) HEALTH SCIENCE INTERNATIONAL, INC. 1043 Complaint N. Dear Health & Science, I used the Serenity cream for over four months after I was diagnosed with abnormal Endometrial cells. My Doctor insisted I get a hysterectomy. His reasoning that I was 48 years old, had three children, no plans for more and the cells could end up cancerous. I told him I wanted to use the cream for a few months and then have another biopsy. He became quite angry with me saying “Why don’t you just do what I say?!” and he went on to say that the cream could not be regulated and would not help me.

Before the biopsy this first doctor had recommended HRT for me.

Needless to say, I switched to another doctor. When I investigated on the internet I found out about Serenity. I used it for over 4 months and then my new doctor did a D&C. She said we will try it but 95% of the cases are the same - but maybe we will have a miracle.

Well, we did - my cells were all 100% normal. So I am very grateful to Serenity for Women. * * * (Exhibit A at 25.) O. Estrogens (estradiol, estrone, estriol) are predominately female hormones, and in adults, they are important for maintaining the health of the reproductive tissues, breasts, skin and brain. Excessive estrogens can cause fluid retention, weight gain, migraines and over stimulation of the breasts, ovaries and uterus, leading to cancer, endometriosis, polycystic ovaries, uterine fibroid tumors. VOLUME 144 Complaint * * * Most scientists now agree that by-products of estrogen metabolism are the cause of breast cancer, ovarian cancer and prostate cancer.

Progesterone is a hormonal balancer, particularly of estrogens. It enhances the beneficial effect of estrogens while preventing the problems associated with estrogen excess. . .

* * * All of the research we have reviewed, the many years of clinical experience of Dr. John Lee (California, USA) and the six years clinical experience we have with tens of thousands of women worldwide cause us to conclude that natural progesterone is safe and free of side effects (when administered topically) and addresses the underlying causes of many hormone related health problems that plague women, including infertility, polycystic Ovaries and ovarian cancer.

(Exhibit A at 26-27.) P. A commonality of the worlds' industrialized societies is the prevalence of uterine fibroids, fibrocystic breast disease, breast and/or uterine cancer, PMS, premenopausal bone loss as well as a high incidence of postmenopausal osteoporosis.

* * * Because natural progesterone is the biological precursor for the production of natural estrogen, it is the natural choice for menopausal women as well as for premenopausal women to enjoy optimal health, free of the HEALTH SCIENCE INTERNATIONAL, INC. 1045 Complaint risks and side effects associated with synthetic hormones. Additionally, natural progesterone will stimulate the body’s natural bone building cells (osteoblasts), offer significant protection against stroke and heart disease and benefit virtually every cell and organ of the body. * * * Natural Progesterone has been found to be safe and effective when applied topically, in a cream formula free from petrochemicals and animal by-products. (Exhibit A at 28.) Q. There are no reports of any significant side effects or health problems associated with natural progesterone when it is administered in a properly formulated Natural Progesterone Cream.

(Exhibit A at 30.) R. According to Dr. Stanley West, Chief Endocrinologist at St. Vincent’s Hospital in New York, U.S, 90% of the hysterectomies performed in the United States each year are unnecessary surgery. According to Dr. John Lee those women who are told that they have “pre-cancerous” cells after a gynecological exam, need only supplement with a properly formulated natural progesterone cream and implement the known dietary/lifestyle modifications, and the so called “pre-cancerous” cells will diminish along with the need for surgery.

(Exhibit A at 32.) 9. Through the means described in Paragraphs 7 and 8, Respondents have represented, expressly or by implication, that: A. Serenity for Women Natural Progesterone Cream is effective in preventing, treating, or curing osteoporosis; VOLUME 144 Complaint B. Serenity for Women Natural Progesterone Cream is effective in preventing or reducing the risk of estrogen-induced endometrial (uterine) cancer; and C. Serenity for Women Natural Progesterone Cream does not increase the user’s risk of developing breast cancer and/or is effective in preventing or reducing the user’s risk of developing breast cancer.

10. Through the means described in Paragraphs 7 and 8, Respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraph 9, at the time the representations were made.

11. In truth and in fact, Respondents did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 9 at the time the representations were made. Therefore, the representation set forth in Paragraph 10 was, and is, false or misleading.

12. Through the means described in Paragraphs 7 and 8, Respondents have represented, expressly or by implication, that clinical testing proves that Serenity for Women Natural Progesterone is effective in preventing, treating, or curing osteoporosis. 13. In truth and in fact, clinical testing does not prove that Serenity for Women Natural Progesterone is effective in preventing, treating, or curing osteoporosis. Therefore, the representation set forth in Paragraph 12 was, and is, false or misleading. 14. The acts and practices alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission Act. HEALTH SCIENCE INTERNATIONAL, INC. 1047 Complaint THEREFORE, the Federal Trade Commission, on this thirteenth day of November, 2007, has issued this complaint against respondents.

By the Commission.

VOLUME 144 Complaint Exhibit A HEALTH SCIENCE INTERNATIONAL, INC.

Complaint eaten we ying RN A AU RR I oe AOI OU oe —Index of Diseases ~The Experts ~Product Information ->-—__Shop Online The Informed Woman:

Overview Breast Cancer Depression Estrogen Dominance Estrogen, Progesterone And Breast Cancer Does Progesterone or Estrogen increase or decrease my risk for cancer? Fertility & Progesterone iy cular biologist, Dr. Ben Formby of Copenhagen, Denmark and Dr, T.S. Wiley at the Hot Flashes Insomnia Ubido « Menopause Migraines Natural Progesterone Osteoporosis Ovarian Cancer PMS Learn More:

University of California in Santa Barbara have researched two genes, BCL2 and P53, and their effect on female-specific cancers and prostate cancer. Cells of breast, endometrium, ovary and prostate, were grown in the laboratory, Estrogen (estradiol) was added to the cells. This hormone turned on the BCL2 gene, causing the cells to grow rapidly and not die. Then, progesterone was added to the cell cultures. Cell reproduction stopped and the cells died on time (apoptosis). This methodology was applied to all the above types of cancer. The BCL2 gene, therefore, stimulates the growth of these cells and the risk of cancer. On the other hand, the PS3 gene promotes apoptosis or programmed cell death and thereby, reduces the Brain Function & AgINS isk of cancer. Estradiol upregulates or stimulates the production of the BCL2 gene, Diet/Lifestyle Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards while progesterone upregulates or stimulates the production of the P53 gene. Therefore natural progesterone decreases the risk for several types of cancer, while unopposed estradiol causes these same types of cancer. Since Breast cancer is considered to be a hormone dependent cancer it is critically Important to maintain optimal levels of natural progesterone and avoid’ the factors that would promote too Synthetic-Progesterone much estradiol Tissue Cleansing Are Birth Control Pills Safe? In order for natural progesterone to stimulate the production of the P53 gene it must attach itself to progesterone receptors found in abundance in breast, ovarian, and * endometrial cells. If a woman is taking birth contro! pills or any other form of synthetic Progesterones (progestins, progesterone acetate, medroxy-progesterone acetate) these synthetic progesterones will occupy progesterone receptors and prevent natural Progesterone from occupying the receptor site. Synthetic progesterones not only fall to produce the P53 gene but prevent it's production by blocking natural progesterone from occupying the progesterone receptor and in the presence of excess estradiol, dramatically increase a woman's risk for female-specific cancers. There are 12 references to tests on BCL2 and PS3, and how they are affected by Progesterone & estrogen, This information has been published, in part, in the following journals:

@ The American Cancer Society Journal @ The Journal of Clinical Endocrinology @ The American Journal of Pathology ® International Journal of Cancer ® The Journal of the American Medical Association (JAMA) © Fertility and Sterility - Journal of the American Society For Reproductive Medicine Clearly the underlying causes of breast cancer are too much estrogen relative to too little natural progesterone, especially in the presence of trans fatty acids (hydrogenated fats).

“When faced with decisions on critically important health issues such as breast cancer, ovarian cancer, endometriosis, fibrocystic breast disease, migraine headaches, infertility & osteoporosis, Informed Women demand and deserve the finest natural progesterone cream formula available anywhere in the world “Serenity for Women Certified Potency Progesterone Cream." a j -2- | o——Contact Us oa cage rus | Home | Sign In | ene Premature Birth - :

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HEALTH SCIENCE INTERNATIONAL, INC.

Complaint TP AAMAR AL A AU UNNR EER oe AANHMLRLE UU ULL oe —Index of Diseases The Experts c-Product Information 5_Shop Online oO. The Informed Womart:

Overview Breast Cancer Depression Estrogen Dominance What Is Progesterone? Progesterone is the single most important hormone made by the female body. It Is Fertility & Progesterone critically Important for the health of virtually every cell and organ of the body. Hot Flashes Insomnia Libido Menopause Migraines Natural Progesterone Osteoporosis Ovarian Cancer PMS Brain Function & Aging Diet/Lifestyle Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards Because progesterone is a. master hormone, It is used as a precursor for the production of other important hormones, such as estrogen and cortisone. Progesterone production, however, can be suppressed by environmental antagonists, such as the hormones found in most commercially grown meats & dairy products, pesticides, petro-chemicals, prescription hormones and stress. Informed women have restored progesterone levels by removing these environmental antagonists, successfully managing stress, Implementing a high fiber diet and consistent use of a properly formulated natural progesterone cream. Some of the other benefits of Natural Progesterone can be accessed from the Natural Progesterone Page! The molecule for Natural Progesterone looks like this: Synthetic-Progesterone Tissue Cleansing Natural progesterone Is remarkably safe and free of side-effects when administered in a proper cream formulation.

SAFE PROGESTERONE rapo.uis | Home | Sign In Contact Us a WY Premature Birth . - — Osteoporosis : .

_——E | infartility Sign In | Uterature Request | Contact Us | SiteMap | FDA Disclaimer | Copyright Information © 1995 - 2007 Health & Science Research, New York, NY, U.S.A. VOLUME 144 Complaint AVAL A AU UO US oe KAUR UI ULE oe —Index of Diseases ——The Experts o-Product Information:;—_Shop Online Contact Us a The Informed Womarc Overview Breast Cancer Depression Natural Progesterone Estrogen Dominance Natural progesterone is made by the ovaries prior to menopause and by the adrenal Fertility & Progesterone glands and fat cells after menopause and Is the precursor for natural estrogen. It Is the Hot Flashes Insomnia Libido Menopause Migraines single most important hormone in the female body. [+] More When the female body fails to produce enough progesterone between ovulation and menstruation and during menopause, natural transdermal progesterone cream can address the underlying cause of most symptoms, Natural Progesterone Osteoporosis Ovarian Cancer PMS Because the female body uses natural progesterone to make natural estrogen, a Properly formulated natural progesterone cream is the natural safe choice for menstruating women and for post-menopausal women seeking to establish the correct balance of their two primary female hormones, Brain Function & Aging This balance of Natural Progesterone and Natural Estrogesns will protect them from the Diet/Lifestyle effects of the condition knwon as “Estrogen Dominance".* Fluoride Toxicity a a porosis ‘The resultant Benefits of natural progesterone include Intestinal Health Helps Use Fat for Energy Microwave Hazards Facilitates Thyroid Hormone Action Synthetic-Progesterone Natura! Antl-depressant Tissue Cleansing Natural Diuretic Normalizes Blood Sugar Levels Restores Proper Cell Oxygen Levels Restores Libido Normalizes Menstrual Cycles Normatlizes Zinc & Copper Levels Normalizes Blood Clotting Protects Against Breast Fibrocysts Helps Protect Epithellal cells against Breast Cancer Helps Prevent Endometrial Cancer.

Helps prevent Ovarian Cysts and Ovarian Cancer Precursor for Cortisone Production (Arthritis) ‘Stimulates Osteoblast Cells (Osteoporosis Reversal) As you can see, natural progesterone counterbalances the effects of too much estrogen discussed here.

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Complaint UDICUPULUDID aI1U LY@LULa FLUBOSUCLUNG .. SICAL OUIENUS.CULL .. —Index of Diseases — The Experts -Product Information 4—Shop Online co——Contact Us a The Informed Woman:

Overview Breast Cancer Depression Estrogen Dominance Osteoporosis & Natural Progesterone Osteoporosis is a disorder In which progressive bone mass loss and demineralization Fertility & Progesterone increase ones risk of fracture. This condition permits us to observe how prescription Hot Flashes Insomnia Libido Menopause Migraines Natural Progesterone Osteoporosis Ovarian Cancer PMS Learn More:

progestins and estrogens compare to Natural Progesterone. The standard medical protocol for osteoporosis Is to use estrogen, (commonly synthesized from pregnant mare’s urine), in spite of the fact that the most authoritative | medical textbooks do not support It.

The following article Illustrates:

“Estrogens decrease bone resorption" but “associated with the decrease In bone resorption is a decrease In bone formation. Therefore, estrogens should not be expected to increase bone mass."** Brain Function & Aging Diet/Lifestyle Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards Scientific American's Updated Medicine Text, 1991. Bone tissue should be broken down and rebuilt continuously, just like all of the cells in our body. This process takes place when Osteoclasts help to dissolve old bone tissue, while osteoblasts stimulate new bone growth. Because estrogen has a rate limiting effect Synthetic-Progesterone on Osteoclasts, Estrogen Dominance delays the breakdown of bone tissue but does not Tissue Cleansing support bone building (osteoblast function). Natural progesterone, on the other hand, stimulates osteoblast production which results in new bone tissue growth. Consequently, estrogens only slow down bone loss, not promote the formation of new bone tissue. Osteoporosis Research The efficacy of natural progesterone is verified by a three year study of 63 postmenopausal women with osteoporosis.** Women using transdermal progesterone cream experienced an average 7-8% bone mass density increase the first year, 4-5% the second year and 3-4% the third yeart Untreated women in this age category typically lose 0.7% to 2.0% bone mineral density per year!!! These results have not been found with any other form of hormone replacement therapy, prescription medication or dietary supplement! Conclusion Maintaining proper levels of natural progesterone, giving due attention to dietary choices, dietary calcium, managing stress and regular exercise are all vital components of strong, healthy bones.

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Complaint DOUBELOWU Vou UI AvatUIal FIUBZOSIGLUUG UiGaLl .. LAGaILI-OUIGULS.LUUL .. —Index of Diseases ——The Experts Depression Estrogen Dominance Suggested Use Of Natural Progesterone Cream Progesterone is very well absorbed transdermally (through the skin) where It is stored in Fertility & Progesterone the fatty tissues for use as needed and unlike progesterone taken orally, It Is not subject Hot Flashes Insomnia Libido Menopause Migraines Natural Progesterone Osteoporosis Ovarian Cancer PMS Brain Function & Aging Diet/Lifestyle Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards to being intercepted by the liver. For those women who are especially deficient in progesterone, It may take three to twelve months to restore optimal levels. For men with prostate disorders results may be felt within one or two days, but long term benefits may require six months.

In the morning and at bedtime, the cream should be gently massaged by the palms of the hands to areas of the body where one blushes: the face, neck, chest, upper arms and other areas of the body that may benefit from progesterone, e.g. breasts, abdomen, back of neck.

Serenity for Wornen is a Certified Potency Cream that contains not less than 1,260 mg. of Natural Progesterone per (60 grams) 2.1 ounces. Informed women have chosen a procedure that is in the following paragraph. PMS & Infertility Begin using creme 12 days from the first day of menstruation. Use approximately 1/8 teaspoon twice per day (morning and at bedtime). Stop using the cream on day 26. Synthetic-Progesterone Women with more severe PMS or endometriosis have chosen to initially use twice the Tissue Cleansing Sign In | Literature Request | ContactUs | Site Map | FDA Disclaimer | Copyright Information suggested amount of crear (1/4 teaspoon twice daily) for the first one or two months. In addition, women who experience uterine cramping have chosen to apply the cream just above the pubic area at the onset of cramps. Women who experience hormone related headaches have applied he cream to the sides of the neck and just behind the | earlobe, at the onset of headaches.

Menopause or Post Hysterectomy The créme should be applied 24 days out of the month and then discontinued for 6-7 days. Apply 1/8 teaspoon twice per day morning and at bedtime for all 24 days. Women who have severe menopausal symptoms have chosen to initially apply twice as much cream (1/4 teaspoon twice dally) for the first one or two months. In addition, women who are experiencing hot flashes have chosen to apply a small dab of the cream to the inside of the wrist at the onset of a hot flash. For those few women who still experience hot flashes, night sweats and/or vaginal dryness a natural estriol cream can be safely used for several months.

Osteoporosis The cream should be applied 24 days of the month and then discontinued for 6-7 days. Apply 1/8 teaspoon twice per day morning and at bedtime for all 24 days. Informed Men have used Serenity 1/16th of a teaspoon at bedtime, 24 days per month. Side Effects: There are no reports of any significant side effects or health problems associated with natural progesterone.

A few women may experience temporarily experience an increase In the symptoms caused by too much estrogen such as Incidental spotting and/or swelling of the breasts. This is normally alleviated within a few days or weeks with the normalizing of hormone levels.

Any persistent problems should always be checked by a qualified physician. co-Product Information >—Shop Online =>———Contact Us o ragcoarurs | Home | Sign In Ws Premature Birth Osteoporosis pon Infertility © 1995 - 2007 Health & Science Research, New York, NY, U.S.A. 8.

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Complaint USLOUPULUDIS £ACYGUUUL Git AAULULYDUL DAGMSL LISCUSG .. CICHILI-OUICHUG.LULL .. —Index Depression Estrogen Dominance Fertility & Progesterone Hot Flashes Insomnia Libido Menopause Migraines Natural Progesterone Osteoporosis Ovarian Cancer PMS Learn Mere: ___ Brain Function & Aging Diet/Lifestyle Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards Synthetic-Progesterone Tissue Cleansing of Diseases ~The Experts o-Product Informationcj>—_Shop Online = >—_Contact Us o Osteoporosis Prevention Dear Health & Science Iam 54 and have been using Serenity for Women for over 3 years now. Recently, I had my first bone density test. I was very scared because I had a number of risk factors for osteoporosis. The results of my test? Bones of a 25 year old! My Doctor had never seen such a high rating for someone my age. Tam amazed! Barbara McCrady Maine, U.S.

Fibrocystic Breast Disease Dear Health & Science, I want to congratulate you on the production of Serenity for Women, Natural Progesterone Cream.

Although I had tried other "natural progesterone" creams in the past, Serenity for © Women has been, by far, the most effective, consistent, and reliable one for the symptoms I was experiencing.

It has virtually stopped my hot flashes, eliminated the pain and swelling I had from cystic breasts, and even stabilized my moods! Truly, this one product has made this time of my life much smoother and easier. I wish I had it 20 years ago! On behalf of my husband and myself, a hearty, Thank You! Yours Truly.

Sandra Thomas, Registered Nurse Naturopathic Doctor New Hampshire, U.S.

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We Osteoporosis ° ° Infertility Signin | Literature Request | ContactUs | SiteMap | FDA Disclaimer |. Copyright Information © 1995 - 2007 Health & Science Research, New York, NY, U.S.A. -10- | VOLUME 144 Complaint nnn AUN UES oe A RUMOR IU oe aagvauise —Index of Diseases ~ ~The Experts (Product Information 4—_Shop Online o——Contact U: o Home | Sign In Calcium And Osteoporosis Estrogen Dominance Bone Architecture Hor oY as Bone structure is made up of calcium and phosphorous crystals embedded in a Insomnia framework of interlocking protein fibers. Hydroxyapatite (Bone-Up™) is the form of Libido calcium found in human bone tissue and is the predominant structural form of calcium. Menopause Tt is responsible for 67% of the total bone weight, the remaining 33% being composed Migraines by collagen fibers (Rheumatol Forte™). Osteoporosis The mi se Ovarian Cancer mineral crystals give the bone hardness, strength and rigidity. The collagen fibers PMS impart flexibility. Magnesium, fluoride, sodium, potassium, citrate and other trace elements act as a "mortar" that bonds the calcium phosphorous crystals. The hormone calcitonin from the thyroid gland triggers the deposition of calcium by the osteoblast (bone building) cells while parathyroid hormone (parathormone) releases Diet/Lifesytie Fluoride Toxicity calcium from the osteoclast bone cells. Inferuiity Vitamins compose 1% of our total body weight, minerals 4% and calcium and Intectingt Health phosphorous account for 75% of mineral weight. 99% of all calcium Is in the bone and Microwave Hazards teeth with the remaining 1% in the blood and soft tissues. The average adult contains Synthetic-Progesterone 1,000-1,200 grams of calcium or 2.2-2.6 pounds, Tissue Cleansing Osteoporosis Defined Although the percent of circulating calcium is relatively minute, the body’s homeostatic mechanism will continuously cause the bones to release calcium into the bloodstream In order to maintain proper blood levels. So, while serum levels of calcium can test normal, In the absence of sufficient available dietary calcium, bone loss can be significant, this process being a primary cause of osteoporosis. Between 2-4% of a person’s skeleton Is dissolved and rebuilt annually. This process Is implemented by the osteoclast and osteoblast bone cells. Poor nutrition and a suppression of progesterone levels due to stress and other environmental antagonists result in a suppression of the osteoblast bone cell function, in spite of the fact that osteoclast cells continue to dissolve old bone tissue. This condition, especially when there is a loss of collagen, also results in osteoporosis. In the U.S. more than one million fractures occur annually in women 45 years or older, 70% of whom are diagnosed with osteoporosis. Hip fractures carry a mortality rate of 12-15% and are the second leading cause of death in people 47-74 years of age. Of the 190,000 hip fractures that occur annually, 2/3 are due to osteoporosis which costs the U.S. $5 billion each year. Post-menopausal women lose 0.7% to 2.0% of their bone per year; men lose 0.5%-0.7%. Between the ages of 45 to 70, women lose 30% of their skeletal structure and men lose 15%. Calcium supplementation of 1,000-1,500 mg. per day for persons who consume a high protein diet and 500-750 mg. per day for vegetarians can reduce fracture rates by 50%. Hormonal Influences Because estrogen has a rate limiting effect on Osteociasts, Estrogen Dominance delays the breakdown of bone tissue but does not support bone building (osteoblast function). Natural progesterone, on the other hand, stimulates osteoblast bone cell activity which results In new bone tissue growth. Consequently, estrogens only slow down bone loss, not promote the formation of new bone tissue. Osteoporosis Research The efficacy of natural progesterone Is verified by a three year study of 63 postmenopausal women with osteoporosis. ** Women using transdermal progesterone cream experienced an average 7-8% bone mass density increase the first year, 4-5% the second year and 3-4% the third year! Untreated women in this age category typically lose 0.7% to 2.0% bone mineral density -W1- Weight Loss

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Breast Cancer Estrogen Dominance Depression Estrogen Dominance Natural progesterone Is produced by the corpus luteum after ovulation and balances the Weight Loss Fertility side effects of otherwise unopposed estrogen. cssotuneeceneecssonenneenenenees Hot Flashes Insomnia Under influences of anovulatory cycles, menopause, stress and dietary antagonists, Ubido progesterone production ceases or is suppressed and the effects of Estrogen Dominance, Menopause can be observed. Many women experience otherwise unexplained weight gain from the Migraines Jack of progesterone that is required for proper thyroid function.* Hot Flashes Osteoporosis hessutuinsesseen seu Ovarian Cancer It Is also important that we distinguish Natural Progesterone from Yam extract and from PMS Its counterparts In the drug Industry - PROGESTINS. Although these drugs are commonly referred to as progesterone, this is a misnomer. In some ways they mimic the Ls More effects of progesterone in the body, but in other important ways they gravely interfere Brain Function & Aging with natural progesterone and can create and exacerbate hormone related health Diet/Lifesytie problems, and be a primary contributor to the condition referred to as Estrogen Osteoporosis Fluoride Toxicity Dominance: — And Osteoporosis .

Infertility * Increased Body Fat Intestinal Health @ Interference with Thyroid Hormone Activity (hypo-thyrold) Microwave Hazards @ Depression & Headaches P Synthetic-Progesterone © Salt and Water Retention Tissue Cleansing ® Blood Sugar Irregularities (Food Cravings) ® Reduced Oxygen in All Celis © Decreased Libido (Sex Drive) @ Loss of Zinc and Retention of Copper *® Excessive Blood Clotting ® Increased Risk of Breast Cancer Reduced Vascular Tone Increased Risk of Endometrial Cancer © Endometriosis @ Uterine Cramping © Infertility © Increased Risk of Uterine Cancer When the above list of Ill-effects is compared to the benefits of Natural Progesterone, we see a nearly one-to-one correlation.

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Complaint AAU YUE UTA PIUB OULU PIVatwy .. b LUBCOLCLUIL CULL aupeauiy —Index of Diseases The Experts o-Product Information -— Shop Online o——Contact Us Home | Sign In Depression Estrogen Dominance Fertility Hot Flashes Insomnia Libido Menopause Migraines Osteoporosis Ovarian Cancer PMS Diet/Lifesyte Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards Synthetic-Progesterone Tissue Cleansing Following are Contraindicataions, Warnings, Precautions, and Adverse Reactions by the manufaturer of published "Sythetic Progesterone" (medroxy-progesterone acetate) Provera (Medroxyprogesterone Acetate, Progestins) Warning: The use of Medroxyprogesterone Acetate during the first four months of pregnancy Is NOT recommended.

Progestational agents have been used beginning with the first trimester of pregnancy in an attempt to prevent habitual abortion. There is no adequate evidence that such use Is effective when such drugs are given during the first four months of pregnancy. Furthermore, in the vast majority of women, the cause of abortion is a defective ovum, which progestational agents could not be expected to Influence. In addition, the use of progestational agents, with their uterine-relaxant properties, in patients with fertilized defective ova may cause a delay in spontaneous abortion. Therefore, the use of such “~ drugs during the first four months of pregnancy is not recommended. Several reports suggest an association between intrauterine exposure to progestational drugs In the first trimester of pregnancy and genital abnormalities in male and female fetuses. The risk of hypospadias, 5 to 8 per 1,000 maie births in the general population, may be approximately doubled with exposure to these drugs. There are insufficient data to quantify the risk to exposed female fetuses, but insofar as some of these drugs induce mild virilization of the external genitalia of the female fetus, and because of the increased association of hypospadias in the male fetus, it is prudent to avoid the use of these drugs during the first trimester of pregnancy. If the patient is exposed to PROVERA Tablets (medroxyprogesterone acetate) during the first four months of pregnancy or if she becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus. Description PROVERA Tablets contain medroxyprogesterone acetate, which Is a derivative of progesterone. It Is a white to off-white, odorless crystalline powder, stable in alr, melting between 200 and 210 C. It is freely soluble in chloroform, soluble In acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in either, and insoluble In water, The chemical name for medroxyprogesterone acetate is Pregn-4-ene-3,20-dione, 17- (acetyloxy)-6-methyl-, (6a)-. The structural formula Is: Each PROVERA tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxy-progesterone acetate. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc. The 2.5 mg tablet contains FD&C Yellow -14- | Hot Flashes VOLUME 144 Complaint AA UAE TAA PLU BOUL UU UOLOIG) .. A AUBDDIGLUNO.LULU .. no. 6, The information contained in the box only is not from the manufaturer of synthetic progesterone Contrastingly, the molecule for Natural Progesterone looks like this: CH | Progesterone c=0 cH3 chy This is the molecule made by the female body and the exact same molecule found in a Properly formulated natural progesterone cream. Or. John Lee, of California, U.S.A., used natural progesterone creams in his practice for 19 years. He states in his books that natural progesterone. Is remarkably safe and free of side-effects when administered in @ proper cream formulation.

Actions Medroxyprogesterone acetate, administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug ls apparently devoid of significant estrogenic activity. While parenterally administered medroxyprogesterone acetate Inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data Indicate that this does not occur when the usually recommended oral dosage Is given as single dally doses. Indications and usage Secondary amenorrhea; abnormal uterine bleeding due to hormonal Imbalance in the absence of organic pathology, such as fibroids or uterine cancer. Contraindications for Medroxyprogesterone Acetate 1. Thrombophiebitis, thromboembolic disorders, cerebral apoplexy or patients with a past history of these conditions.

2. Uver dysfunction or disease.

3. Known or suspected malignancy of breast or genital organs. 4. Undlagnosed vaginal bleeding. 5.Missed abortion. 5. Asa diagnostic test for pregnancy.

» 6 Known sensitivity to PROVERA Tablets. Warnings for Medroxyprogesterone Acetate 1. The physician should be alert to the earliest manifestations of thrombotic disorders (thrombophlebitis, cerebrovascular disorders, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.

2. Beagle dogs treated with medroxyprogesterone acetate developed mammary nodules some of which were malignant. Although nodules occasionally appeared in control animals, they were intermittent in nature, whereas the nodules In the drugtreated animals were larger, more numerous, persistent, and there were some breast malignancies with metastases. Their significance with respect to humans has not been established.

3. Discontinue medication pending examination If there is sudden partial or complete loss of vision, or if there is @ sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn, 4. Detectable amounts of progestin have been identified in the milk of mothers -15rage zur HEALTH SCIENCE INTERNATIONAL, INC. 1063 Complaint ae ee etme rey paw geeewn eee sae 66k AUB UU ULL oe fagoou. receiving the drug. The effect of this on the nursing infant has not been determined.

5. Usage In pregnancy is not recommended (See WARNING Box). 6. Retrospective studies of morbidity end mortality in Great Britain and studies of morbidity in the United States have shown a statistically significant association between thrombophlebitis, pulmonary embolism, and cerebral thrombosis and embolism and the use of oral contraceptives.1-4 The estimate of the relative risk of thromboembolism in the study by Vessey and Doll3 was about sevenfold, while Sartwell and associates4 In the United States found a relative risk of 4.4, meaning that the users are several times as likely to undergo thromboembolic disease without evident cause as nonusers. The American study also indicated that the risk did not persist after discontinuation of administration, and that it was not enhanced by long continued administration. The American study was not designed to evaluate a difference between products. Precautions for Medroxyprogesterone Acetate 1. The pretreatment physical examination should Include special reference to breast and pelvic organs, as well as Papanicolaou smear. 2. Because progestogens may cause some degree of fluid retention, conditions which might be influenced by this factor, such as epilepsy, migraine, asthma, cardiac or renal dysfunction, require careful observation. 3. In cases of breakthrough bleeding, as In all cases of irregular bleeding per vaginum, nonfunctional causes should be borne In mind. In of undiagnosed vaginal bleeding, adequate diagnostic measures are indicated. 4, Patients who have a history of psychic depression should be carefully observed and the drug discontinued If the depression recurs to a serious degree. 5. Any possible influence of prolonged progestin therapy on pitultary, ovarian, adrenal, hepatic or uterine functions awalts further study. 6. A decrease in glucose tolerance has been observed in a small percentage of patients on estrogen-progestin combination drugs. The mechanism of this decrease is obscure. For this reason, diabetic patients should be carefully observed while receiving progestin therapy.

7. The age of the patient constitutes no absolute limiting factor although treatment with progestins may mask the onset of the climacteric. 8. The pathologist should be advised of progestin therapy when relevant specimens are submitted, 9. Because of the occasional occurrence of thrombotic disorders, (thrombophlebitis, pulmonary embolism, retinal thrombosis, and cerebrovascular disorders) in patients taking estrogen-progestin combinations and since the mechanism is obscure, the physician should be alert to the earliest manifestation of these disorders.

10. Studies of the addition of @ progestin product to an estrogen replacement regimen for seven or more days of a cycle of estrogen administration have reported a lowered incidence of endometrial hyperplasia. Morphological and biochemical studies of endometrium suggest that 10-13 days of a progestin are needed to provide maximal maturation of the endometrium and to ellminate any hyperplastic changes. Whether this will provide protection from endometrial carcinoma has not been clearly established. There are possible additional risks which may be associated with the inclusion of progestin in estrogen replacement regimen. The potential risks Include adverse effects on carbohydrate and lipid metabolism. The dosage used may be important in minimizing these adverse effects. 11. Aminoglutethimide administered concomitantly with PROVERA may significantly depress the bioavailability of PROVERA.

Carcinogenes, Mutagenesis, Impairment of Fertility Long-term intramuscular administration of PROVERA has been shown to produce mammary tumors in beagle dogs (see WARNINGS). There was no evidence of a carcinogenic effect associated with the oral administration of PROVERA to rats and mice. Medroxyprogesterone acetate was not mutagenic in a battery of in vitro or in vivo genetic toxicity assays.

Medroxyprogesterone acetate at high doses Is an antifertility drug and high doses would be expected to impair fertility until the cessation of treatment. Adverse reactions to Medroxyprogesterone Acetate Pregnancy-(See WARNING Box for possible adverse effects on the fetus). Breast-Breast tenderness or galactorrhea has been reported rarely. Skin-Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred In an occasional patient. Acne, alopecia and hirsutism have been reported in a few cases. | VOLUME 144 Complaint Re aT ER PA QUALI EARLY ek DUB UOLULUTI ALLL oe Thromboembolic Phenomena-Thromboembolic phenomena including thrombophiebitis and pulmonary embolism have been reported. The following adverse reactions have been observed In women taking progestins including PROVERA Tablets: breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, edema, change in weight (increase or decrease), changes in cervical erosion end cervical secretions, cholestatic jaundice, enaphylactoid reactions and anaphylaxis, rash (allergic) with and without pruritus, mental depression, pyrexia, insomnia, nausea, somnolence.

A statistically significant association has been demonstrated between use of estrogenprogestin combination drugs and the following serious adverse reactions: thrombophlebitis; pulmonary embolism and cerebral thrombosls and embolism. For this reason patients on progestin therapy should be carefully observed. Although available evidence Is suggestive of an association, such a relationship has been neither confirmed nor refuted for the following serious adverse reactions:. neuro-ocular lesions, eg, retinal thrombosis and optic neuritis. ‘The following adverse reactions have been observed In patients receiving estrogenprogestin combination drugs: rise in blood pressure in susceptible individuals, fatigue, backache, hirsutism, premenstruel-like syndrome, loss of scalp halr, erythema multiforme, changes in libido, erythema nodosum, changes in appetite, hemorrhagic eruption, cystitis-like syndrome, headache, itching, nervousness, dizziness. In view of these observations, patients on progestin therapy should be carefully observed.

The following laboratory results may be altered by the use of estrogen-progestin combination drugs: Increased sulfobromophthalein retention and other hepatic function tests. Coagulation tests: increase in prothrombin factors VIL, VIII, IX and X. Metyrapone test. Pregnanediol determination, Thyroid function: Increase In PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values. Dosage and administration for Medroxyprogesterone Acetate Secondary Amenorrhea-PROVERA Tablets may be given in dosages of 5 to 10 mg daily for from 5 to 10 days. A dose for Inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of PROVERA dally for 10 days. In cases of secondary amenorrhea, therapy may be started at any me. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing PROVERA therapy. Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology-Beginning on the calculated 16th or 2ist day of the menstrual cycle, 5 to 10 mg of medroxyprogesterone acetate may be given dally for from 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of medroxyprogesterone acetate dally for 10 days beginning on the 16th day of the cycle Is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with PROVERA, Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with PROVERA.

How supplied PROVERA Tablets are available in the following strengths and package sizes: 2.5 mg (scored, round, orange) Bottles of 30 NDC 0009-0064-06 Bottles of 100 NDC 0009-0064-04 5 mg (scored, hexagonal, white) Bottles of 30 NDC 0009-0286-32 Bottles of 100 NDC 0009-0286-03 10 mg (scored, round, white) Bottles of 30 NDC 0009-0050-09 Bottles of 100 NDC 0009-0050-02 Bottles of 500 NDC 0009-0050-11 DOSEPAK-3 Unit of Use (10) NDC 0009-0050-12 ‘Store at controlled room temperature 15-30 C (59-86 F). References Faye ur.

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Complaint 2 AV STORE (ACLU A PAU BCOLMAULI AUULALLY ok AUB COLCLUUG-CLUELL 1. Royal College of General Practitioners: Oral contraception and thromboembolic disease. J Coll Gen Pract 13:267-279, 1967. 2. Inman WHW, Vessey MP: Investigation of deaths from pulmonary, coronary, and cerebral thrombosis and embolism in women of child- bearing age. Br Med J 2:193-199, 1968.

3. Vessey MP, Doll R: Investigation of relation between use of oral contraceptives and thromboembolic disease. A further report. Br Med ) 2:651-657, 1969. 4. Sartwell PE, Masi AT, Arthes FG, et al: Thromboembolism and oral contraceptives: An epidemiological case-control study. Am J Epidemiol 90:365-380, 1969. Patient Information PROVERA Tablets contain medroxyprogesterone acetate a synthetic progesterone. The information below Is that which the U.S. Food and Drug Administration requires be provided for all patients taking medroxyprogesterone acetates. The Information below relates only to the risk to the unborn child associated with use of medroxyprogesterone acetate during pregnancy. For further information on the use, side effects and other risks associated with this product, ask your doctor or read the information WARNING FOR WOMEN Medroxyprogesterone acetate or progesterone-like drugs have been used to prevent miscarriage in the first few months of pregnancy. No adequate evidence is available to show that they are effective for this purpose. Furthermore; most cases of early miscarriage are due to causes which could not be helped by these drugs. There is an increased risk of minor birth defects In children whose mothers take this drug during the first 4 months of pregnancy. Several reports suggest an association between mothers who take these drugs in the first trimester of pregnancy and genital abnormalities in male and female babies. The risk to the male baby Is the possibility of being born with a condition in which the opening of the penis Is on the underside rather than the tip of the penis (hypospadias). Hypospadias occurs in about 5 to 8 per 1,000 male births and is about doubled with exposure to these drugs. There is not enough information to quantify the risk to exposed female fetuses, but enlargement of the clitoris and fusion of the labia may occur, although rarely. Therefore, since drugs of this type may Induce mild masculinization of the external genitalia of the female fetus, as well as hypospadias In the male fetus, it is wise to avoid using the drug during the first trimester of pregnancy. These drugs have been used as a test for pregnancy but such use is no longer considered safe because of possible damage to a developing baby. Also, more rapid methods for testing for pregnancy are now available. If you take PROVERA and later find you were pregnant when you took it, be sure to discuss this with your doctor as soon as possible. rage Jul.

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VOLUME 144 Complaint A AVA, SAOMMUUHE GUL OULLLDIUL AAGALLUCMID .. FAUZCOUCAUUG.CULL «. rage.ois —Index of Diseases ~The Experts Home | Sign In Overview Breast Cancer Depression Estrogen Dominance Fertility Hot Flashes Insomnia Libido Menopause Migraines Osteoporosis Ovarian Cancer PMS & Aging Diet/Lifesytle Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards Synthetic-Progesterone Tissue Cleansing PMS - Traditional & Successful Treatments Traditional PMS Treatments Traditional treatments have included tranquilizers, diuretics, dietary changes, thyroid supplements, herbs, vitamins, exercise, acupuncture and psychiatric counseling. While these may provide some easing of symptoms, the underlying causes remain. Successful Treatments Dr. Joel T. Hargrove of Vanderbilt University Medical Center has seen some success In treating PMS with oral doses of natural progesterone.* The problem with oral progesterone administration, however, Is that the liver intercepts approximately 90% of the hormone. So, in order to achieve a net dose of 20 mg. the typical dose prescribed Is 200 mg. per day. The liver thus converts progesterone to progesterone metabolites, which work against natural hormone function. The more natural method of raising progesterone levels is free from side-effects. This has been well documented by the high rate of success reported by Dr. John R. Lee, M.D., using Transdermal Natural Progesterone in his practice for approximately 19 years and the success reported to the Health & Science Research Institute from thousands of women around the world.

Finally, oral progesterone will produce a sharp rise in serum progesterone levels followed by a rapid drop within about an hour. Progesterone administered via a properly formulated progesterone cream will raise systemic progesterone levels for eleven or twelve hours. This offers informed women continual and stable progesterone levels which may play a critical role in the prevention of female specific cancers, the amelioration of the symptoms of PMS & Menopause, the ability to get and stay pregnant, and the reversal of Osteoporosis. (Bone loss in women who live in industrialized countries begins, on average, at age 35). In thirty years of clinical practice, seventeen recommending transdermal natural progesterone, Dr, Lee has observed the consistent benefits and safety of natural progesterone therapy. He makes this statement: “Though not completely understood, PMS most commonly represents an individual reaction to estrogen dominance, secondary to relative progesterone deficiency. Appropriate treatment requires- correction of this hormone imbalance in conjunction with known dietary lifestyle modifications and the most effective technique, at present, for achieving this Is supplemental Transdermal Natural Progesterone."** Letters from Our Ladies Some Observations from Medical Doctors -Product Information 5—.Shop Online o— Contact Us o 1 SignIn | Literature Request | ContactUs | SiteMap | Privacy & Security | Copyright © 1995 - 2007 Health Science Research, NY, NY, U.S.A. -19-— \ HEALTH SCIENCE INTERNATIONAL, INC.

Complaint AAA GUIS AYE A AUBUOLULUUIG «6 A LUBCDICLUNG.CULL o rage tus —Index of Diseases The Experts Product Information 5>_Shop Online Home | Sign In Breast Cancer Depression Estrogen Dominance Fertility Hot Flashes Insomnia Libido Menopause Migraines Osteoporosis Ovarian Cancer PMS Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards Synthetic-Progesterone Tissue Cleansing Libido & Natural Progesterone The Female Body manufactures many types of Estrogen but only one Progesterone and Natural Progesterone is the Source of Libido or Sex Drive In Women! Sources of Natural Progesterone Natural Progesterone Is normally produced by the female ovaries right after ovulation and balances the side effects of otherwise unopposed estrogen. Under the Influences. of dietary estrogens, petrochemicals, stress, and menopause, Progesterone production ceases or is suppressed and the effects of Estrogen Dominance, can be observed.

Most women expertence Loss of Libido, mood swings, Irritability, anger, depression, headaches and weight gain from the lack of Progesterone that is required for proper thyroid function, Natural Transdermal Progesterone Cream, applied topically to the face, neck, arms, chest and fatty tissue areas of the body such as the breasts, the abdominal area, the buttocks, the inner thighs, etc., is stored In these fatty tissues for use as required by the body and has been shown to reverse the effects of Estrogen Dominance listed below: ® Increased Body Fat © Anger, Rage @ Depression; © Uterine Cramping ® Migraine Headaches © Water Retention © Blood Sugar Irregularities © Loss of Zinc, Retention of Copper @ Excessive Blood Clotting @ Increased Risk of Breast Cancer. Reduced Vascular Tone © Increased Risk of Ovarian Cancer Endometriosis Increased Risk of Endometrial Cancer © Infertility e Restraint of Osteoclast Function © Interference with Thyroid Function (bone loss) © Loss of Libido (Sex Drive) @ Reduced Oxygen in All Cells (Foggy Brain) It Is also Important that we distingulsh Natural Progesterone from Its counterparts In the drug industry - PROGESTINS. Although these drugs are commonly referred to as Progesterone, this Is a misnomer.

In some ways they mimic the effects of Natural Progesterone in the body, but in other important ways they gravely interfere with Natural Progesterone and can create and exacerbate hormone related health problems, and be a primary contributor to Estrogen Dominance.

Traditional Treatments Traditional treatments have included tranquilizers, diuretics, dietary changes, thyroid supplements, herbs, vitamins, exercise, acupuncture end psychiatric counseling. While these may provide some easing of symptoms, the underlying causes remain. © Successful Treatments — - -20 - | o——Contact Us o Hot Flashes

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Complaint AALS CAL FIUBCSICLUIIC WACMIUIS WIG OMS 2. FLORES ISrUlIS.COL 2: rage 2 un Z —Index of Diseases The Experts -Product Information >—_Shop Online Home | Sign In c——Contact Us a Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards Synthetic-Progesterone Tissue Cleansing Are All "Progesterone" Creams The Same? The task of selecting an effective “progesterone” cream can be a challenging one. Women are bombarded by a constant supply of new companies selling “progesterone” creams, often times started by those who have no nutritional or health care experience. In @ desperate attempt to generate income many of these companies will use marketing techniques that emphasize fantastic commission checks to their distributors, who, In thelr heightened state of about to be realized “financial independence", will tell the consumer almost anything.

Further, Many “popular creams" sold today contain litte or no Progesterone USP, or contain inconsistent levels:

e@ Each 2 oz (57 g) pot of Pro-Gest® Cream (Emerita™) contains 200 mg of progesterone...

@ This assay was done on tubes of Pro-Gest® cream purchased by mail over a period of 5 months! *The Lancet Medical Journal, (Volume 351, Number 9111, 25 April 1998) Complicating matters is the fact that, at one time, one of the components of Yam (dioscorea villosa), diosgenin, was believed to be. converted in the female body to progesterone. In fact, in his first book, Dr. John Lee of California, U.S.A., states that diosgenin Is probably converted to Progesterone, However, that has since been proven to be unsubstantiated and, in fact, In his current book, "What Your Dr. May Not Tell You About Menopause” on page 270, Dr. Lee states *...there is no evidence that the human body converts diosgenin to hormones.”

Dr. David Zava, (PhD In Blo Endocrinology whose focus has been progesterone and estrogen receptor activity) Is the laboratory director of Aeron Life Cycles, one the foremost hormone testing facilities in the world, Dr. Zava has tested progesterone levels for many thousands of women and responded with the following: "In response to your question about wild yem steroids - do they convert into progesterone? The answer Is no, there are no enzymes in the human body that will convert diosgenin, the active component of wild yams, into progesterone. This does not mean diosgenin Is without activity in the body as it has been used by phytotherapists for centuries as an adaptagen."

So, when selecting @ progesterone cream for the purpose of raising bio-available progesterone levels, the first criteria that must be met is that the cream must contain sufficient levels of USP Natural Progesterone and be a Certified Potency Cream! The cream must also be properly formulated. Second and equally as important, the consumer benefits by the selection of a company that is adequately staffed or owned by Health Care Consultants who are trained in natural, side-effect free approaches to optimal health.

Considering the normal healthy monthly female cycle, we observe, in response to ovulation, that progesterone levels increase from 2-3 mg. per day to 22-25 mg. per day for 12 to 14 days just prior to menstruation. Because there are many cream companies Promoting @ product that contains only a few milligrams of progesterone per ounce or none, those formulations are unable to have a positive effect on biologically available levels of progesterone.

Consequently, the typical response from women using a “yam cream" or a cream that does not have a certified potency has been: © Itseems to have helped a little, but it is not what I really need.” Conversely, women who use a properly formulated certified potency progesterone cream =22-

HEALTH SCIENCE INTERNATIONAL, INC. 1071 Complaint AB AAY AMAU AAO GU CARE CULUP@LIDUL .. £ LUZ CSUGLUNIS.UULL Frage 1ui4 —Index of Diseases ~4—_The Experts c-Product Information >—_Shop Online o——Contact Us o Serenity Products — Home ] Sign In All Products The Informed woman Products by Catagory Overview Breast Cancer Price Information & Cream Comparison Depression .

Estrogen Dominance Many “populer creams" sold today contain little or no Progesterone USP, or at best, have Fertility inconsistent levels of progesterone. Hot Flashes Insomnia "Each 2 oz (57 q) pot of Pro-Gest® cream (Emerita™) contains 200 mg of Libido progesterone..." * Menopause (This assay was done on tubes of Pro-Gest® cream purchased by mail over a period of 5 Migraines months) Osteoporosis *The Lancet Medical Journal, (Volume 351, Number 9111, 25 April 1998). Ovarian Cancer P PMS Additionally, most creas, including those that claim to be “progesterone” creams are formualted with petrochemicals.

When faced with decisions on critically Important issues such as breast cancer, ovarian . cancer, endometriosis, fibrocystic breast disease, migraine headaches, infertility and Osteoporosis Fluoride Toxicity osteoporosis, informed women demand and deserve the finest cream available anywhere “srr And Osteoporosis in the world.

Infertility Intestinal Health Serenity for Women, Certified Potency, Natural Progesterone Cream Microwave Hazards Other Products Synthetic-Progesterone Tissue Cleansing | Signin | Literature Request | ContactUs | SiteMap | Privacy &Security | Copyright | © 1995 - 2007 Health Science Research, NY, NY, U.S.A. -24- VOLUME 144 Complaint FLYDUCLOLLUIY KAGYGHUUL .. CLUB GOUCLUUG.CUUL .. sage aU’ —Index of Diseases (>——The Experts -Product Informationc;——_Shop Online = ~3—__Contact Us o Home | Sign In Hysterectomy Prevention Estrogen Dominance a Sheila Simons) Fertility Hot Flashes Dear Health & Science, somnle I used the Serenity cream for over four months after I was diagnosed with abnormal bre Endometrial cells.

Menopause Migraines My Doctor insisted I get a hysterectomy. His reasoning that I was 48 years old, had Osteoporosis three children, no plans for more and the cells could end up cancerous. I told him I Ovarian Cancer wanted to use the cream for a few months and then have another biopsy. He became PMS quite angry with me saying "Why don't you just do what I say?!" and he went on to say that the cream could not be regulated and would not help me. Diet/ti . Before the biopsy this first doctor had recommended HRT for me. Hot Flashes Fluoride Toxicity Needless to .

And Osteoporouie leedless to say, I switched to another doctor. Infertility When I Investigated on the internet I found out about Serenity. I used it for over 4 Intestinal Health months and then my new doctor did a D&C. She said we will try it but 95% of the cases microwave rezarts ie are the same - but maybe we will have a miracle. Tissue Cleansing Well, we did - my cells were all 100% normal. So I am very grateful to Serenity for Women. I would have had an unnecessary operation if 1 had not investigated and took charge of my own health.

And by the way, I always put my situations in God's hands and this was an answer to my prayers. : ;

Thank-you Shella Simons Van Nuys, California, USA I Sign In | Literature Request | ContactUs | Site Map | Privacy & Security | Copyright | © 1995 - 2007 Health Science Research, NY, NY, U.S.A. -25 - | HEALTH SCIENCE INTERNATIONAL, INC.

Complaint UValialt CAUCE .. £LUBCSLCLUNC.CULL ..

fapoius —Index of Diseases ——The Experts Home | Sign In Depression Estrogen Dominance Fertility Hot Flashes Insomnia Ubido Menopause Migraines Osteoporosis Ovarian Cancer Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards Synthetic-Progesterone Tissue Cleansing Ovarian,Cancer Typically, lower fertilization retes are found In women who have polycystic ovaries rather than those with tubal disease or endometriosis. Increased levels of estrogen stimulate increased levels of testosterone and androgen (increased body hair). Increased androgen (hyper-androgenism) has been shown to be critical in the pathogenesis or development of polycystic ovaries and ovarian cancer. Mechanisms by which androgens induce cyst formation, however, have not yet been elucidated. It has been hypothesized that ovarian androgen excess produces larger follicles and increased apoptosis, resulting in cyst formation and follicular atresia (death and regression of an ovarian follicle).

Hyper-androgenism, therefore, produces larger follicles and Increased apoptosis. Apoptosis is the process by which a cell runs Its life course and actively “commits suicide".

It is now well recognized that apoptosis is essential in many aspects of normal development and is required for. maintaining tissue homeostasis. Failure to properly regulate apoptosis can have catastrophic consequences. Cancer and many diseases (AIDS, Alzheimer's disease, Parkinson's disease, heart attack, stroke, etc.) are thought to arise from deregulation of apoptosis.

The basic roles, therefore, performed by estrogen and progesterone are Estrogens (estradiol, estrone, estriol) are predominately female hormones, and in adults, they are important for maintaining the health of the reproductive tissues, breasts, skin and brain. Excessive estrogens can cause fluid retention, weight gain, migraines and over stimulation of the breasts, ovaries and uterus, leading to cancer, endometriosis, polycystic ovaries, uterine fibroid tumors. Insufficient estrogen levels or fluctuations of estrogen can lead to hot flushes, vaginal dryness, rapid skin aging, urinary problems, excessive bone loss and possible acceleration of dementia. An excess of estrogen, relative to testosterone, Is thought to play a role In the development of prostate problems in men. Most scientists now agree that by-products of estrogen metabolism are the cause of breast cancer, ovarian cancer and prostate cancer.

Progesterone is a hormonal balancer, particularly of estrogens. It enhances the beneficial effect of estrogens while preventing the problems associated with estrogen excess, which includes Polycystic Ovaries. Natural Progesterone also helps regulate apoptosis. Progesterone also helps create a balance of all other steroids. It also has intrinsic calming and diuretic properties. Progesterone is the “Pro-Gestational” hormone and Is the single most important hormone for conception and full-term pregnancy. It Is Important in women, but it’s Importance in men for the maintenance of prostate health is only now being appreciated. So, whether a woman conceives through traditional “naturel pregnancy" or IVF Fertility Treatment, it is critically important that she maintain optimal levels of progesterone throughout pregnancy. A drop in progesterone levels or a blockade of progesterone receptors during the first 11 or 12 weeks of pregnancy will often result in loss of the embryo.

Dr. Catherine Dalton has suggested that pregnant women use a properly formulated natural progesterone cream until the start of the third tri-mester when the placenta takes over progesterone production. She further states that women who maintain high progesterone levels during pregnancy produce healthier and more intelligent children, Polycystic Ovaries A 29 year old woman In the United States presented with excessive facial/body = 26. | o-Product Information -;__Shop Online co——Contact Us oa VOLUME 144 Complaint UValidlt Care! .. PeUYCOIGLUUC.CULL .. fagoeus hair growth, acne, and weight galn about the waist. She had suffered with these problems since puberty and had been on several of the popular low fat/high carbohydrate diets, which helped with weight temporarily, but resulted in rebound weight gain, Menstrual periods were also irregular. Saliva testing during the second half of the menstrual cycle (luteal phase) indicated high-normal estradiol, low Progesterone, and high androgens-both DHEAS and testosterone. Further examination by her doctor revealed cystic ovaries. Dietary modification (removal of simple, refined carbohydrates-pastas, chips, pastries, sodas etc.) and use of natural progesterone has helped restore normal menstrual cycles, resolve the cystic ovaries and reduce the risk for ovarian cancer. All of the research we have reviewed, the many years of clinical experience of Dr. John Lee (California, USA) and the six years clinical experience we have with tens of thousands of women worldwide cause us to conclude that naturel progesterone Is safe and free of side effects (when administered topically) and addresses the underlying causes of many hormone related health problems that plague women, Including infertility, polycystic Ovaries and ovarian cancer. 1 Sign In | Uterature Request | ContactUs | Site Map | Privacy &Security | Copyright | © 1995 - 2007 Health Science Research, NY, NY, U.S.A. 7“ ~ HEALTH SCIENCE INTERNATIONAL, INC. 1075 Complaint JMIGHUPAUSG, LOUUECH AUU 1 ULL SICMIL .. LACALLUMOUISULS.CUUL .. tage ius | Home | Sign in —Index of Diseases (5—_The Experts o-Product Information-j;——_Shop Online ©} —~_Contact Us Oo The Informed Woman: a) Overview Breast Cancer Menopause, Estrogen & Your Health Depression Estrogen Dominance Menopause Overview Forilty & Progesterone 4 commonality of the worlds’ industrialized societies Is the prevalence of uterine fibroids, Insomnia fibrocystic breast disease, breast and/or uterine cancer, PMS, pre-menopausal bone loss \___ ls Ubido as well as a high incidence of post-menopausal osteoporosis. Pramature Birth beoreles Significantly, the common thread weaving Its way through all of these conditions is ne Natural Progesterone estrogen dominance, secondary to an insufficiency of progesterone. However, after : Osteoporosis menopause or a hysterectomy, estrogen production decreases by about 40% to 60%. In Ovarian Cancer other words the female body still produces estrogen at about 40% to 60% of pre- PMS menopause levels.

Learn More: Because natural progesterone Is the biological precursor for the production of natural Brain Function & Aging estrogen, It Is the natural choice for menopausal women as well as for pre-menopausal \ , Diet/Lifestyle Aging women to enjoy optimal health, free of the risks and side effects associated with Osteoporosis Fluorid se synthetic hormones. Additionally, natural progesterone will stimulate the body's natural . . Puoride Toxicky bone building cells (osteoblasts), offer significant protection against stroke and heart | _- Infertility porosis disease and benefit virtually every cell and organ of the body. Intestinal Health By establishing a balance of these hormones through proper Diet, Stress Management Microwave Hazards and Natural Progesterone supplementation, fluctuations of estrogen and progesterone, Synthetic: Progestarone the resultant hot flashes, night sweats and other symptoms of menopause are either no significantly alleviated or completely eliminated. ee Persistent Symptoms Infertility For those women for whom hot flashes, night sweats and/or vaginal dryness still persist they have found that 400 |.u. of natural vitamin E three times per day (1200 I.u./day), essential oil supplementation (primrose oll, omega III) and four to six tablespoons of whole psyllium seed husks in juice dally has been effective in ameliorating these persistent symptoms.

In cases where Estrogen Replacement Therapy Is elected to control hot flashes, vaginal dryness or night sweats, natural estriol cream is recommended usually for several months or, in some cases a year. This is a safe, non-cancer promoting form of phytoestrogen available here.

In most cases, however, estriol is not needed when a sufficient amount of Natural Progesterone Is available, as it Is the precursor (raw material) for other adrenal hormones, Including all three forms of natural estrogen and cortisone. Safety of Natural Hormones Natural Progesterone has been found to be safe and effective when applied topically, In @ cream formula free from petrochemicals and animal by-products. Risks of HRT This is In contrast to the standard medical protocol of HRT. Studies have shown that women taking replacement estrogen have a 2 to 8 times higher risk of developing breast cancer, ovarian cancer and endometrial cancer than women who do not take estrogen. The risk increases after 2 to 4 years of estrogen use and seems to be greatest when large doses (>1 mg./day) are taken or when the estrogens are used for long periods of time (>4 years). This risk factor increases sharply in women who smoke cigarettes.

Sleuthing a Thyroid Mystery by Dr. Stephen Langer -28- |

HEALTH SCIENCE INTERNATIONAL, INC.

Complaint CICILY LUE WW ULNCH NU .. LGA OUIGNLS.CULL .. —Index of Diseases <The Experts -Product Information >——Shop Online The Informed Woman:

Overview Breast Cancer Depression Estrogen Dominance Serenity For Women Info Product Description Fertility & Progesterone cerenity for Women is The Finest Quality Moisturizing Cream that contains not less than Hot Flashes Insomnia Libido Menopause Migraines Natural Progesterone Osteoporosis Ovarian Cancer PMS Learn More:

Brain Function & Aging Diet/Lifestyle Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards Synthetic-Progesterone Tissue Cleansing 1,260 mg. of USP Natural Progesterone (converted from plant sources) per 2.1 ounce (60 gram) jar (Why a Jar? Isn't a tube better) This is the optimal progesterone level for @ proper cream formulation. (Fragrance Free & HYPO-ALLERGENIC) Ingredients Purlfled Water, Organic Aloe Vera Ge! 200:1 Concentrate (Aloe Barbadenis), Vegetable Glycerin, Natural Progesterone USP (2.1%), Vegepure (Complex, Stabilized Vegetable Oil), Natural Vitamin E, Glyceryl Stearate (from plant), Stearic Acid (from plant), Cety! Alcohol (from plant), PEG-20 Methyl Glucose Sesquistearate (from plant), Methyl Glucose Sesquistearate (from plant), Hyaluronic Acid (Natural Skin Molsturizer), NaPCA (Natural Skin Humectant), Xanthan Gum, Citrus Seed Extract (a natural preservative). © Serenity for Women [s formulated with the most advanced delivery system for © maximum absorption (97-100% assimilated) and is light & non-oily. ® The process involves No Animal Testing, No Animal Cruelty and No Animal byproducts.

® A 60-gram jar normally lasts six to twelve weeks, depending on the severity of symptoms and beginning progesterone levels. @ No Petroleum Derivatives or by-products are used in the manufacturing of Serenity for Women.

@ Serenity for Women does not contain Keratin! Suggested Use Please see the Suggested Use Page Precautions There are no reports of any significant side effects or health problems associated with natural progesterone when it is administered in a properly formulated Natural Progesterone Cream.

A few women may temporarily experience an increase In the symptoms caused by too much estrogen. This is not an adverse reaction to progesterone or to the cream, but an increase in the activity of estrogen. This Is often referred to as the “healing crisis* and can be alleviated by strict adherence to the dietary/lifestyle pages. Note; If you are using thyroid medication your health care professional should monitor thyroid function as progesterone may support normal thyroid function and thyroid medication may over stimulate the thyroid gland. Any persistent problems should always be checked by a qualified health care professional.

Related Links Free Dr, Lee book with purchase of three Serenity! o—ContacttUs saguaue | Home | Sign In i] Premature Birth . .

a) Osteoporosis posse —— Infertility Sign In | Literature Request | ContactUs | SiteMap | FDA Disclaimer | Copyright Information © 1995 - 2007 Health & Science Research, New York, NY, U.S.A. -30-

HEALTH SCIENCE INTERNATIONAL, INC.

Complaint JPLYSUCLOCLULLLY 2. PLU ESLCLUNC.CUL 2:

ragoruir Home | Sign In The Informed Woman Overview Breast Cancer Depression Estrogen Dominance Fertility Hot Flashes Insomnia Ubido Menopause Migraines Osteoporosis Ovarian Cancer PMS Fluoride Toxicity And Osteoporosis Infertility Intestinal Health Microwave Hazards Synthetic-Progesterone Tissue Cleansing —Index of Diseases —>—_The Experts Hysterectomy A hysterectomy causes the female body to become immediately menopausal. According to Dr. Stanley West, Chief Endocrinologists at St. Vincent's Hospital in New York, U.S., 90% of the hysterectomies performed in the United States each year are unnecessary surgery. According to Dr, John Lee those women who are told that they have "pre-cancerous" cells after a gynecological exam, need only supplement with a properly formulated natural progesterone cream and implement the known dietary/lifestyle modifications, and the so called "pre-cancerous" cells will diminish along with the need for surgery.

The standard medical decision, however, is to perform a hysterectomy and to give women estrogen replacement therapy, in spite of the fact that 75% of patients still make sufficient amounts of estrogen. This can be verified by a saliva hormone test which measures available levels of estrogen and Is more meaningful than a blood test. After surgery hormone production does not cease, as estrogen and progesterone should still be made by the adrenals & fat cells. The Importance of proper balance of these two hormones Is more critical at this time due to the fact that progesterone plays a critical supportive role in bone building (Osteoblast Cells), stroke prevention and a health heart. Since the female body makes naturel estrogen from natural progesterone, most women -. need only supplement with a properly formulated natural progesterone cream. Some women, however, do not readily make this conversion and may temporarily need supplemental estrogen or may implement a diet that is rich in phyto-estrogens and contains sufficient amounts of fiber.

For the women who need supplemental estrogen due to continued hot flashes, night sweats, and vaginal dryness, 2 natural estriol cream Is e safe and effective treatment. So, for menopause, whether surgically Induced or not, Dr. Lee states In his book, “Adding progesterone will actively increase bone mass and density and can reverse osteoporosis."

Natural progesterone offers many other benefits for women who have had a hysterectomy and they are listed Here.

1>-Product Information -;— Shop Online co——Contact Us Oo | Heart Health Weight Loss Signin | Literature Request | Contact Us [| Site Map | Privacy &Security | Copyright © 1995 - 2007 Health Science Research, NY, NY, U.S.A. VOLUME 144 Decision and Order DECISION AND ORDER The Federal Trade Commission having initiated an investigation of certain acts and practices of the Respondents named in the caption hereof, and the Respondents having been furnished thereafter with a copy of a draft of complaint which the Bureau of Consumer Protection proposed to present to the Commission for its consideration and which, if issued by the Commission, would charge the Respondents with violation of the Federal Trade Commission Act; and The Respondents and counsel for the Commission having thereafter executed an agreement containing a consent order, an admission by the Respondents of all the jurisdictional facts set forth in the aforesaid draft complaint, a statement that the signing of the agreement is for settlement purposes only and does not constitute an admission by the Respondents that the law has been violated as alleged in such complaint, or that any of the facts as alleged in such complaint, other than jurisdictional facts, are true, and waivers and other provisions as required by the Commission’s Rules; and The Commission having thereafter considered the matter and having determined that it had reason to believe that the Respondents have violated the Act, and that a complaint should issue stating its charges in that respect, and having thereupon accepted the executed consent agreement and placed such agreement on the public record for a period of thirty (30) days for the receipt and consideration of public comments, now in further conformity with the procedure prescribed in § 2.34 of its Rules, the Commission hereby issues its complaint, makes the following jurisdictional findings, and enters the following order:

1. Respondent Health Science International, Inc. is a Florida corporation with its principal office or place of business is at 1648 Taylor Road, Suite 118, Port Orange, Florida 32128. HEALTH SCIENCE INTERNATIONAL, INC. 1081 Decision and Order 2. Respondent David Martin is an officer of Health Science International, Inc. Individually, or in concert with others, he formulates, directs, controls, or participates in the policies, acts, or practices of Health Science International, Inc. His principal office or place of business is the same as that of Health Science International, Inc.

3. The Federal Trade Commission has jurisdiction of the subject matter of this proceeding and of the Respondents, and the proceeding is in the public interest.

ORDER DEFINITIONS For purposes of this order, the following definitions shall apply: 1. Unless otherwise specified, “Respondents” shall mean: a. Health Science International, Inc., a corporation, and its successors and assigns and its officers; and b. David Martin, individually and as an officer of Health Science International, Inc.

2. “Competent and reliable scientific evidence” shall mean tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.

3. “Progesterone product” shall mean any product containing or purporting to contain any progestagen (whether natural or synthetic), including but not limited to progesterone (whether produced by the human body or produced outside VOLUME 144 Decision and Order the human body but having the same chemical structure as the progesterone produced by the human body) or any progestin, including but not limited to Serenity for Women Natural Progesterone Cream.

4. “Food,” shall mean (a) articles used for food or drink for man or other animals, (b) chewing gum, and (c) articles used for components of any such article.

5. “Drug” shall mean (a) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; (c) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (d)articles intended for use as a component of any article specified in clause (a), (b), or (c); but does not include devices or their components, parts, or accessories.

6. “Device” shall mean an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (a) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (c) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. HEALTH SCIENCE INTERNATIONAL, INC. 1083 Decision and Order 7. “Covered product or service” shall mean any dietary supplement, food, drug, device, or any health-related service or program.

8. “Commerce” shall mean commerce among the several States or with foreign nations, or in any Territory of the United States or in the District of Columbia, or between any such Territory and another, or between any such Territory and any State or foreign nation, or between the District of Columbia and any State or Territory or foreign nation. 9. “Endorsement” shall mean any advertising message (including verbal statements, demonstrations, or depictions of the name, signature, likeness or other identifying personal characteristics of an individual or the name or seal of an organization) which message consumers are likely to believe reflects the opinions, beliefs, findings, or experience of a party other than the sponsoring advertiser. The party whose opinions, beliefs, findings, or experience the message appears to reflect will be called the endorser and may be an individual, group or institution.

I.

IT IS THEREFORE ORDERED that Respondents, directly or through any person, partnership, corporation, subsidiary, division, trade name, or other device, in connection with the labeling, advertising, promotion, offering for sale, sale, or distribution of any Progesterone product or any other covered product or service, in or affecting commerce, shall not represent, in any manner, expressly or by implication, including through the use of a product name or endorsement:

A. That such product or service is effective in preventing, treating, or curing osteoporosis;

VOLUME 144 Decision and Order B. That such product or service is effective in preventing or reducing the risk of estrogen-induced endometrial (uterine) cancer;

C. That such product or service does not increase the user’s risk of developing breast cancer;

D. That such product or service is effective in preventing or reducing the user’s risk of developing breast cancer; E. That such product or service is safe for human use or has no side effects;

F. That such product or service is effective in the mitigation, treatment, prevention, or cure of any disease, illness or health conditions; or G. About the health benefits, performance, efficacy, safety, or side effects of such product or service;

unless the representation is true, not misleading, and, at the time it is made, Respondents possess and rely upon competent and reliable scientific evidence that substantiates the representation. II.

IT IS FURTHER ORDERED that Respondents, directly or through any person, partnership, corporation, subsidiary, division, trade name, or other device, in connection with the labeling, advertising, promotion, offering for sale, sale, or distribution of any Progesterone product or any other covered product or service in or affecting commerce, shall not misrepresent, in any manner, expressly or by implication, the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. III.

HEALTH SCIENCE INTERNATIONAL, INC. 1085 Decision and Order IT IS FURTHER ORDERED that:

A. Nothing in this order shall prohibit Respondents from making any representation for any drug that is permitted in labeling for such drug under any tentative final or final standard promulgated by the Food and Drug Administration, or under any new drug application approved by the Food and Drug Administration;

B. Nothing in this order shall prohibit Respondents from making any representation for any product that is specifically permitted in labeling for such product by regulations promulgated by the Food and Drug Administration pursuant to the Nutrition Labeling and Education Act of 1990; and C. Nothing in this order shall prohibit Respondents from making any representation for any device that is permitted in labeling for such device under any new medical device application approved by the Food and Drug Administration. IV.

IT IS FURTHER ORDERED that Respondents shall, for five (5) years after the last date of dissemination of any representation covered by this order, maintain and upon reasonable notice make available to the Federal Trade Commission for inspection and copying:

A. All advertisements and promotional materials containing the representation;

B. All materials that were relied upon in disseminating the representation; and C. All tests, reports, studies, surveys, demonstrations, or other evidence in their possession or control that contradict, VOLUME 144 Decision and Order qualify, or call into question the representation or the basis relied upon for the representation, including complaints and other communications with consumers or with governmental or consumer protection organizations.

V.

IT IS FURTHER ORDERED that Respondents shall delivery a copy of this order to all current and future principals, officers, directors, and managers, and to all current and future employees, agents, and representatives having responsibilities with respect to the subject matter of this order, and shall secure from each such person a signed and dated statement acknowledging receipt of the order. Respondents shall deliver this order to current personnel within thirty (30) days after the date of service of the order, and to future personnel within thirty (30) days after the person assumes such position or responsibilities.

VI.

IT IS FURTHER ORDERED that Respondents shall notify the Commission at least thirty (30) days prior to any change with regard to Health Science International, Inc. or any business entity that any Respondent directly or indirectly controls, or has an ownership interest in, that may affect compliance obligations arising under this order, including but not limited to incorporation or other organization; a dissolution, assignment, sale, merger, or other action that would result in the emergence of a successor entity; the creation or dissolution of a subsidiary, parent, or affiliate that engages in any acts or practices subject to this order; the proposed filing of a bankruptcy petition; or a change in the business or corporate name or address. Provided, however, that, with respect to any proposed change about which Respondents learn less than thirty (30) days prior to the date such action is to take place, Respondents shall notify the Commission as soon as is practicable after obtaining such knowledge. All notices required by this Part shall be sent by HEALTH SCIENCE INTERNATIONAL, INC. 1087 Decision and Order certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. VII.

IT IS FURTHER ORDERED that Respondents, for a period of seven (7) years after the date of issuance of this order, shall notify the Commission of the discontinuance of their current business or employment; or of their affiliation with any new business or employment. The notice shall include respondent’s new business address and telephone number, a description of the nature of the business or employment, and their duties and responsibilities. All notices required by this Part shall be sent by certified mail to the Associate Director, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580.

VIII.

IT IS FURTHER ORDERED that Respondents shall, within sixty (60) days after service of this order, and, upon reasonable notice, at such other times as the Federal Trade Commission may require, file with the Commission a report, in writing, setting forth in detail the manner and form in which they have complied with this order.

IX.

This order will terminate on November 13, 2027, or twenty (20) years from the most recent date that the United States or the Federal Trade Commission files a complaint (with or without an accompanying consent decree) in federal court alleging any violation of the order, whichever comes later; provided, however, that the filing of such a complaint will not affect the duration of: VOLUME 144 Analysis to Aid Public Comment A. Any Part in this order that terminates in less than twenty (20) years;

B. This order’s application to any Respondent that is not named as a Respondent in such complaint; and C. This order if such complaint is filed after the order has terminated pursuant to this Part.

Provided, further, that if such complaint is dismissed or a federal court rules that the Respondent did not violate any provision of the order, and the dismissal or ruling is either not appealed or upheld on appeal, then the order will terminate according to this Part as though the complaint had never been filed, except that this order will not terminate between the date such complaint is filed and the later of the deadline for appealing such dismissal or ruling and the date such dismissal or ruling is upheld on appeal.

By the Commission.

ANALYSIS OF PROPOSED CONSENT ORDER TO AID PUBLIC COMMENT The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Health Science International, Inc., a corporation, and David Martin, individually and as an officer of Health Science International ( together, “respondents”). The proposed consent order has been placed on the public record for thirty (30) days for reception of comments by interested persons. HEALTH SCIENCE INTERNATIONAL, INC. 1089 Analysis to Aid Public Comment Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received and will decide whether it should withdraw from the agreement or make final the agreement’s proposed order.

This matter involves the advertising and promotion of Serenity for Women Natural Progesterone Cream, a transdermal cream that, according to its label, contains, among other ingredients, natural progesterone. According to the FTC complaint, respondents represented that Serenity for Women Natural Progesterone Cream: (1) is effective in preventing, treating, or curing osteoporosis; (2) is effective in preventing or reducing the risk of estrogen-inducted endometrial (uterine) cancer; and (3) does not increase the user’s risk of developing breast cancer and/or is effective in preventing or reducing the user’s risk of developing breast cancer. The complaint alleges that respondents failed to have substantiation for these claims. The complaint also alleges that respondents misrepresented that clinical testing proved that Serenity for Women Natural Progesterone is effective in preventing, treating, or curing osteoporosis. The proposed consent order contains provisions designed to prevent respondents from engaging in similar acts and practices in the future.

Part I of the proposed order requires respondents to have competent and reliable scientific evidence substantiating claims that any progesterone product or any other dietary supplement, food, drug, device or health-related service or program is effective in preventing, treating, or curing osteoporosis, in preventing or reducing the risk of estrogen-induced endometrial cancer or breast cancer, or in the mitigation, treatment, prevention, or cure of any disease, illness, or health condition; that it does not increase the user’s risk of developing breast cancer, is safe for human use, or has no side effects; or about its health benefits, performance, efficacy, safety, or side effects.

VOLUME 144 Analysis to Aid Public Comment Part II of the proposed order prevents respondents from misrepresenting the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research. Part III of the proposed order provides that the order does not prohibit respondents from making representations for any drug that are permitted in labeling for the drug under any tentative final or final Food and Drug Administration (“FDA”) standard or under any new drug application approved by the FDA; representations for any medical device that are permitted in labeling under any new medical device application approved by the FDA; and representations for any product that are specifically permitted in labeling for that product by regulations issued by the FDA under the Nutrition Labeling and Education Act of 1990.

Parts IV through VIII require respondents to keep copies of relevant advertisements and materials substantiating claims made in the advertisements; to provide copies of the order to certain of their personnel; to notify the Commission of changes in corporate structure and changes in employment that might affect compliance obligations under the order; and to file compliance reports with the Commission. Part IX provides that the order will terminate after twenty (20) years under certain circumstances. The purpose of this analysis is to facilitate public comment on the proposed order. It is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.

PROGESTERONE ADVOCATES NETWORK 1091 Complaint