NCT00682890

Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

Inclusion criteria: PCOS women between the ages of 18-45,\< 8 periods annually, elevated serum free testosterone, normal thyroid function tests and serum prolactin, exclusion of late onset adrenal hyperplasia, acceptable health based on interview and medical history, physical exam and lab tests, ability to comply with the requirements of the study and to provide signed, witnessed informed consent.

Conditions

• Polycystic Ovary Syndrome
• PCOS
• Insulin Sensitivity

Interventions

Type	Name	Description
DRUG	placebo	placebo birth control pill daily
DRUG	metformin	2000 mg per day for 3 months daily birth control pill

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2008-05-23
• Last updated: 2014-08-20
• Results posted: 2014-08-20

Locations

1 site across 1 country: United States