Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370019
Status:
WITHDRAWN
Last Update Posted:
2017-07-02
First Post:
2006-08-29
Brief Title:
Effects of an Estrogen Replacement Therapy Skin Patch on Ovulation in Women With Premature Ovarian Failure
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effect of Transdermal Estradiol Replacement Therapy on Ovulation Rate in Women With Premature Ovarian Failure A Randomized Placebo-Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2011-12-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 uL except in the preovulatory stage when it rises above 20 uL 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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-CH-0201 | None | None | None |