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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: Completed Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
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
What the finished NCT00001951 record still lists
NCT00001951 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 1 intervention - of which TMTDS is the first listed.
NCT00001951 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00001951's enrollment target sits among peer trials
250 222nd of 2000 higher than 1,768 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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