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NCT00001951 · ClinicalTrials.gov registry record · Phase 2
Hormone Replacement in Young Women With Premature Ovarian Failure
A Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT00001951 is a Phase 2 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 250 participants.
The verdict
NCT00001951, a Phase 2 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
The human ovary produces male sex hormones (androgen) and female sex hormones (estrogen). Currently, androgen is not included in hormone replacement therapy for women with premature ovarian failure. Present hormone replacement therapy (HRT) was designed to treat women who experience ovarian failure at menopause (around the age of 50). However, 1% of women will experience premature failure of the ovaries before the age of 40. There have been no studies conducted to determine proper hormone replacement therapies for these younger women. Some research suggests that the usual menopausal hormone replacement therapy is not adequate to protect young women with premature ovarian failure from developing osteoporosis. Women with premature ovarian failure have abnormally low levels of androgens circulating in their blood. This may contribute to the increase risk for osteoporosis. This study will compare two treatment plans for women with premature ovarian failure. Treatment plan one will be physiological estrogen hormone replacement. Treatment plan two will be physiological estrogen hormone replacement plus androgen. The study will attempt to determine which plan is more beneficial to women in relation to osteoporosis and heart disease. The hormones will be contained in patches and given by placing the patches against the patient's skin. The patches were designed to deliver the same amount of hormone as would be normally produced by the ovary in young women. The success of the treatment will be measured by periodically checking the density of patient's bone in the leg (femoral neck bone) . Researchers will take an initial (baseline) measurement of bone density before beginning treatment and then once a year, for 3 additional years, during treatment. The study will also consider bone density of the spine, bone turnover, heart disease risk factors, and psychological state.
Interventions
- DRUG TMTDS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 1999-12 |
| Est. Completion | 2006-10 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001951
The ClinicalTrials.gov registry entry for NCT00001951 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TMTDS is the first listed.
NCT00001951 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001951 about?
NCT00001951 is a clinical study titled "Hormone Replacement in Young Women With Premature Ovarian Failure". The human ovary produces male sex hormones (androgen) and female sex hormones (estrogen). Currently, androgen is not included in hormone replacement therapy for women with premature ovarian failure. Present hormone replacement therapy (HRT) was designed to treat women who experience ovarian failure ...
What is the current status of trial NCT00001951?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 1999-12. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00001951?
The interventions under investigation include: TMTDS (DRUG).
Who is sponsoring clinical trial NCT00001951?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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