1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARClNOMA IN POSTMENOPAUSAL WOMEN.
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that "natural" estrogens are more or less hazardous than "synthetic" estrogens at equi-estrogenic doses.
2. ESTROGENS SHOULD NOT BE USED DURING PREGNANCY.
There is no indication for estrogen therapy during pregnancy or during the immediate postpartum period. Estrogens are ineffective for the prevention or treatment of threatened, or habitual abortion. Estrogens are not indicated for the prevention of postpartum breast engorgement.
Estrogen therapy during pregnancy is associated with an increased risk of congenital defects in the reproductive organs of the fetus, and possibly other birth defects. Studies of women who received diethylstilbestrol (DES) during pregnancy have shown that female offspring have an increased risk of vaginal adenosis, squamous cell dysplasia of the uterine cervix, and clear cell vaginal cancer later in life; male offspring have an increased risk of urogenital abnormalities and possibly testicular cancer later in life. The 1985 DES Task Force concluded that use of DES during pregnancy is associated with a subsequent increased risk of breast cancer in the mothers, although a causal relationship remains unproven and the observed level of excess risk is similar to that for a number of other breast cancer risk factors.
OGEN VAGINAL SUMMARY
estropipate vaginal cream, USP
OGEN (estropipate vaginal cream, USP), (formerly piperazine estrone sulfate), is a natural estrogenic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. Each gram of OGEN Vaginal Cream contains 1.5 mg estropipate.
OGEN Vaginal Cream is indicated for the treatment of vulval and vaginal atrophy.
Published Studies Related to Ogen Vaginal (Estropipate)
The effects of different types and doses of oestrogen replacement therapy on clinic and ambulatory blood pressure and the renin-angiotensin system in normotensive postmenopausal women. [1999.03]
OBJECTIVE: The effect on blood pressure of oral replacement' doses of exogenous oestrogen may depend on the type and dose of oestrogen administered. This study was designed to compare with placebo the effect of once daily treatment with a 'natural' oestrogen, piperazine oestrone sulphate, in two different doses and a semisynthetic oestrogen, ethinyloestradiol, on clinic and ambulatory blood pressure and the renin-angiotensin system in postmenopausal women... CONCLUSION: In normotensive postmenopausal women, replacement doses of natural and semisynthetic oestrogen reduce night-time ambulatory blood pressure with either no change or a small reduction in clinic blood pressure. Reduction in blood pressure is not explained by reduced activity of the renin-angiotensin system but could have a component of reduced central sympathetic drive consistent with the decreased heart rate.
Menopausal symptom control and side-effects on continuous estrone sulfate and three doses of medroxyprogesterone acetate. Ogen/Provera Study Group. [1998.09]
OBJECTIVES: To establish the optimum oral daily dose of micronized medroxyprogesterone acetate (MPA), given in combination with 1.25 mg of estrone sulfate for menopausal symptom control... CONCLUSIONS: All three treatment regimens provide adequate symptom control. Side-effects decreased markedly after the first 3 months, with no significant difference between the treatment groups.
Bleeding pattern and endometrial changes during continuous combined hormone replacement therapy. The Ogen/Provera Study Group. [1998.05]
OBJECTIVE: To establish the optimum oral daily dose of micronized medroxyprogesterone acetate, given in combination with a fixed oral dose of estrone (E1) sulfate as hormone replacement therapy, that provides endometrial protection and induces cessation of vaginal bleeding... CONCLUSION: All three studied doses of medroxyprogesterone acetate, given in combination with 1.25 mg of E1 sulfate, provide adequate endometrial protection and render approximately 80% of women amenorrheic by 6 months of therapy.
Long-term medical therapy for leiomyomata uteri: a prospective, randomized study of leuprolide acetate depot plus either oestrogen-progestin or progestin 'add-back' for 2 years. [1994.09]
Treatment of women with leiomyomata with gonadotrophin-releasing hormone agonists (GnRHa) for > 6 months is not recommended because of concerns regarding adverse sequelae of prolonged hypoestrogenism. It has been postulated that addition of low-dose sex steroids to GnRHa treatment, i.e... Mean bone density of the lumbar spine as measured by dual X-ray absorptiometry decreased significantly by 2.6% during the first 3 months in all patients, but did not change significantly following steroid add-back in both treatment groups during the final 21 treatment months.(ABSTRACT TRUNCATED AT 250 WORDS).
Effect of orally administered oestrogens on circulating oestrogen profiles in post-menopausal women. [1989.06]
The effect of 4 peroral oestrogen regimens without and with levonorgestrel (LNG) supplementation (250 micrograms/day) was studied in 7 post-menopausal women. The regimens were: A: 2.5 mg piperazine oestrone sulphate/day; B: 1.25 mg piperazine oestrone sulphate + 5.0 mg oestriol/day; C: 2.0 mg oestradiol valerate/day and D: 10.0 mg oestriol/day...
Clinical Trials Related to Ogen Vaginal (Estropipate)
Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults [Active, not recruiting]
Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101) [Active, not recruiting]
The purpose of this study is to evaluate the safety, preliminary efficacy, and
pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions. [Recruiting]
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin
formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal
A Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland [Enrolling by invitation]
Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel [Recruiting]
The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex
hormones, among women suffering from severe PreMenstrual Syndrome (PMS).
The system includes skin testing panel for identification of hormones to which the patients
might be sensitive. Tests are applied close to the ovulation period and the skin reaction is
examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests
and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic
tool for severe PMS patients.
Page last updated: 2006-01-31