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NCT00130117 · ClinicalTrials.gov registry record · Phase 2
Study of Leptin for the Treatment of Hypothalamic Amenorrhea
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00130117 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 20 participants.
The verdict
NCT00130117, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether administration of an investigational medication called leptin (r-metHuLeptin) in replacement doses can improve bone health, reproductive function, hormone levels, immune function, and overall sense of well-being in women with hypothalamic (exercise-induced) amenorrhea (HA) who are being treated with oral contraceptive pills (OCPs), compared to placebo. Women with hypothalamic amenorrhea have low leptin levels. This study is based on the hypothesis that the relative leptin deficiency in women with hypothalamic (exercise-induced) amenorrhea may be the reason for the lack of menstrual cycles, hormone abnormalities, and bone loss associated with this condition.
Interventions
- OTHER Placebo
- DRUG r-metHuLeptin
- DRUG Oral Contraceptive Pills (OCPs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-04 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00130117
The ClinicalTrials.gov registry entry for NCT00130117 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00130117 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00130117 about?
NCT00130117 is a clinical study titled "Study of Leptin for the Treatment of Hypothalamic Amenorrhea". The purpose of this study is to determine whether administration of an investigational medication called leptin (r-metHuLeptin) in replacement doses can improve bone health, reproductive function, hormone levels, immune function, and overall sense of well-being in women with hypothalamic (exercise-i...
What is the current status of trial NCT00130117?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2010-04. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00130117?
The interventions under investigation include: Placebo (OTHER), r-metHuLeptin (DRUG), Oral Contraceptive Pills (OCPs) (DRUG).
Who is sponsoring clinical trial NCT00130117?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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