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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00370019 |
Purpose
This study will determine whether giving estrogen replacement therapy through an estradiol patch can improve ovulation rates in women with spontaneous premature ovarian failure. The ovaries are glands in women that produce female hormones and normally release an egg once a month. In women with spontaneous premature ovarian failure, the ovaries stop working too soon. Women with this disorder have abnormally high levels of leuteinizing hormone (LH) in their blood, which impedes normal ovulation. In some women, estrogen replacement can suppress LH levels to the normal range.
Women between 18 and 40 years of age with premature ovarian failure may be eligible for this 4-month study. Participants receive either standard hormone replacement therapy, consisting of an estradiol patch and progestin tablets, or placebo. The placebo group receives patches and tablets that look the same as those for the group with active treatment but they contain no hormone. All participants wear the patch every day and take the tablets the first 12 days of each month. In addition to taking the study drug, participants have blood drawn once a week for the 16 weeks of the study.
At the end of the trial, women who were in the placebo group are offered the opportunity to receive the estrogen patch and progestin therapy for another 16 weeks and continue the blood tests to determine if they ovulate on this treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Premature Ovarian Failure |
Drug: Estradiol/Medroxyprogesterone acetate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Effect of Transdermal Estradiol Replacement Therapy on Ovulation Rate in Women With Premature Ovarian Failure: A Randomized, Placebo-Controlled Trial |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Premature ovarian failure(POF) is a life altering and distressing diagnosis for women due to associated infertility. Despite having amenorrhea and markedly elevated serum gonadotropin levels, approximately 50% of women with 46XX spontaneous premature ovarian failure have ovarian follicles that function intermittently. These follicles are faced with high serum LH levels. Normally, women have their LH levels in the range of 3-14 u/L except in the preovulatory stage, when it rises above 20 u/L. At that level it works on LH receptors on the granulosa cells and transforms the follicle in the corpus leutium. In POF, continuous high level of LH prematurely lutienizes growing follicles and thereby causes follicle dysfunction. We have shown by histological examination that inappropriate luteinization is a major mechanism of Graffian follicle dysfunction in these women.
We have found that approximately 50% women with premature ovarian failure have LH levels in the normal range while they are taking 100 mcg per day of our standardized transdermal estradiol therapy.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Patients with karyotypically normal spontaneous premature ovarian failure (as defined by screening protocol 91-CH-0127), i.e. women who have at least 4 months of amenorrhea, two FSH levels above 40 mIU/mL, or in the menopausal range, at least one month apart, and a normal 46,XX karyotype, diagnosed with premature ovarian failure prior to the age of 40 who are between the age of 18 and 40 years will be candidates.
Patients will be screened under the protocol 91-CH-0127 (Ovarian follicle function in patients with karyotypically normal spontaneous premature ovarian failure).
EXCLUSION CRITERIA:
hypertriglyceridemia (fasting triglyceride levels greater than 250 mg/dL) undiagnosed vaginal bleeding known sensitivity to agents.
Active liver disease with more than 3 times elevation of liver enzymes.
Contacts and Locations More Information
| Responsible Party: | National Institutes of Health ( Lawrence M. Nelson, M.D./National Institute of Child Health and Human Development ) |
| Study ID Numbers: | 060201, 06-CH-0201 |
| Study First Received: | August 29, 2006 |
| Last Updated: | November 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00370019 History of Changes |
| Health Authority: | United States: Federal Government |
|
Premature Ovarian Failure Ovulation Fertility Estrogen Replacement |
Follicle Function Premature Menopause Premature Ovarian Failure POF |
|
Medroxyprogesterone 17-Acetate Estrogens Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Gonadal Disorders Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Ovarian Failure, Premature |
Reproductive Control Agents Ovarian Diseases Contraceptive Agents, Male Hormones Pharmacologic Actions Estradiol Adnexal Diseases Genital Diseases, Female Therapeutic Uses Contraceptives, Oral, Synthetic Medroxyprogesterone |
