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NCT00682890 · ClinicalTrials.gov registry record · Phase 4
Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
A Phase 4 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT00682890: Clinical Trial Phase 4 study, sponsored by Virginia Commonwealth University.
NCT00682890 is a Phase 4 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00682890, a Phase 4 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS
Primary Outcome
Insulin sensitivity as measured by a combination of insulin sensitivity index (ISI) which should go up after 3 month treatment period to show improvement, and insulin sensitivity (SI) which should go down after 3 month treatment period to show improvement. Note that the ISI as developed by Matsuda and DeFronzo from a calculation based on results from a standard oral glucose tolerance test (OGTT) (doi: 10.2337/diacare.22.9.1462 Diabetes Care September 1999 vol. 22 no. 9 1462-1470) is recorded as
Interventions
- DRUG placebo
- DRUG metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2005-11 |
| Est. Completion | 2010-01 |
| Phase | Phase 4 |
Why NCT00682890 stopped before completion
NCT00682890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00682890 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00682890 about?
NCT00682890 is a clinical study titled "Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)". The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS
What is the current status of trial NCT00682890?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2005-11. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00682890?
The interventions under investigation include: placebo (DRUG), metformin (DRUG).
Who is sponsoring clinical trial NCT00682890?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00682890's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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