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NCT00704912 · ClinicalTrials.gov registry record · Phase 2
Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women
A Phase 2 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 217
- Enrollment target
NCT00704912 is a Phase 2 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 217 participants.
The verdict
NCT00704912, a Phase 2 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 217 participants
- Enrollment target
Study Summary
The goal of this three-armed randomized controlled trial is to establish the relative roles of treatment of hyperandrogenism versus obesity (as the largest modifiable factor contributing to insulin resistance) in treating infertility and improving pregnancy outcomes among obese PCOS women. The investigators hypothesize that the key to restoring ovulation leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the key to avoiding later pregnancy complications is to improve insulin sensitivity with weight loss.
Interventions
- DRUG Orlistat/Meal Replacement/Lifestyle Modification
- DRUG Loestrin 1/20
- DRUG Combination of treatments
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2008-09 |
| Est. Completion | 2014-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00704912
The ClinicalTrials.gov registry entry for NCT00704912 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 217 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Orlistat/Meal Replacement/Lifestyle Modification is the first listed.
NCT00704912 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00704912 about?
NCT00704912 is a clinical study titled "Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women". The goal of this three-armed randomized controlled trial is to establish the relative roles of treatment of hyperandrogenism versus obesity (as the largest modifiable factor contributing to insulin resistance) in treating infertility and improving pregnancy outcomes among obese PCOS women. The inves...
What is the current status of trial NCT00704912?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2008-09. Estimated completion is 2014-03.
What interventions are being tested in trial NCT00704912?
The interventions under investigation include: Orlistat/Meal Replacement/Lifestyle Modification (DRUG), Loestrin 1/20 (DRUG), Combination of treatments (DRUG).
Who is sponsoring clinical trial NCT00704912?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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