Effects of an Estrogen Replacement Therapy Skin Patch on Ovulation in Women With Premature Ovarian Failure
Status:
Withdrawn
Trial end date:
2011-12-12
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)