Protocol Number: 06-CH-0201

Title:

Effect of Transdermal Estradiol Replacement Therapy on Ovulation Rate in Women with Premature Ovarian Failure: A Randomized, Placebo-Controlled Trial

Number:

06-CH-0201

Summary:

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.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Premature Ovarian Failure

Ovulation

Fertility

Estrogen Replacement

Follicle Function

Premature Menopause

Recruitment Keyword(s):

Premature Ovarian Failure

POF

Condition(s):

Premature Ovarian Failure

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Drug: Estradiol/Medroxyprogesterone acetate

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Kreiner D, Droesch K, Navot D, Scott R, Rosenwaks Z. Spontaneous and pharmacologically induced remissions in patients with premature ovarian failure. Obstet Gynecol. 1988 Dec;72(6):926-8.

Santoro N, Schmidt CL. Pregnancy after an unsuccessful oocyte donation cycle. Fertil Steril. 1990 Jan;53(1):174-6.

Wright CS, Jacobs HS. Spontaneous pregnancy in a patient with hypergonadotrophic ovarian failure. Br J Obstet Gynaecol. 1979 May;86(5):389-92.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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