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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: Completed Phase 2 study, sponsored by Milton S. Hershey Medical Center.

NCT00704912 is a Phase 2 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 217 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 217 participants
Start Date 2008-09
Est. Completion 2014-03
Phase Phase 2
Milton S. Hershey Medical Center

396 total trials

What the finished NCT00704912 record still lists

NCT00704912 is an interventional study that assigns participants to a tested intervention. The registered 217 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 (63% higher).

The record links to 0 conditions, and to 3 interventions - of which Orlistat/Meal Replacement/Lifestyle Modification is the first listed.

NCT00704912 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00704912's enrollment target sits among peer trials

217 286th of 2000 higher than 1,715 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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Source: ClinicalTrials.gov NCT00704912, the US trial registry maintained by the National Library of Medicine. NCT00704912 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.