Effects of an Estrogen Replacement Therapy Skin Patch on Ovulation in Women With Premature Ovarian Failure
| Status: | Archived |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
Effect of Transdermal Estradiol Replacement Therapy on Ovulation Rate in Women With Premature Ovarian Failure: A Randomized, Placebo-Controlled Trial
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.
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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
Click here to add this to my saved trials
