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NCT00946192 · ClinicalTrials.gov registry record · Phase 3
Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes
A Phase 3 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 121
- Enrollment target
NCT00946192: Completed Phase 3 study, sponsored by Massachusetts General Hospital.
NCT00946192 is a Phase 3 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 121 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00946192, a Phase 3 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 121 participants
- Enrollment target
Study Summary
One aim of this study is to determine changes in body composition and hormones that differentiate athletes who stop getting their periods versus those who continue to get their periods and non-athletes. The second aim of this study is to determine whether transdermal or oral estrogen (versus no estrogen) is effective in increasing bone density and improving bone microarchitecture in adolescent athletes who are not getting their periods and are thus estrogen deficient. The investigators hypothesize that transdermal estrogen will be more effective than oral estrogen or no estrogen in improving bone health in amenorrheic adolescent athletes.
Primary Outcome
Change in bone density with transdermal estrogen versus oral estrogen or no estrogen in amenorrheic athletes
Interventions
- DRUG Transdermal 17Beta-estradiol, progesterone
- DRUG Ethinyl Estradiol + Desogestrel
- DIETARY_SUPPLEMENT Sham Comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2009-05 |
| Est. Completion | 2021-04 |
| Phase | Phase 3 |
What the finished NCT00946192 record still lists
NCT00946192 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 3 interventions - of which Transdermal 17Beta-estradiol, progesterone is the first listed.
NCT00946192 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00946192 about?
NCT00946192 is a clinical study titled "Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes". One aim of this study is to determine changes in body composition and hormones that differentiate athletes who stop getting their periods versus those who continue to get their periods and non-athletes. The second aim of this study is to determine whether transdermal or oral estrogen (versus no estr...
What is the current status of trial NCT00946192?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 121 participants. The study started on 2009-05. Estimated completion is 2021-04.
What interventions are being tested in trial NCT00946192?
The interventions under investigation include: Transdermal 17Beta-estradiol, progesterone (DRUG), Ethinyl Estradiol + Desogestrel (DRUG), Sham Comparator (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00946192?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00946192's enrollment target sits among peer trials
121 1619th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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