Trials / Completed
CompletedNCT00005654
Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 88 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms. Patients receive oral metformin (arm I) or oral placebo (arm II) three times daily for 8 weeks. All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on days 36-40.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | clomiphene citrate | |
| DRUG | metformin |
Timeline
- Start date
- 2000-01-01
- First posted
- 2000-05-03
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00005654. Inclusion in this directory is not an endorsement.