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

Phase 4

Terminated

• Conditions: Polycystic Ovary Syndrome; Insulin Sensitivity; PCOS
• Interventions: Drug: placebo; Drug: metformin

• Registration Number: NCT00682890
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-22
• Study First Posted: 2008-05-23
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Results First Submitted: 2014-01-21
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-01
• Last Update Submitted: 2014-08-01
• Results First Posted: 2014-08-20
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia

Exclusion Criteria

• Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	Placebo tablet and birth control pill daily
2	metformin	metformin 2000 mg and birth control pill daily

Primary Outcome Measures

Name	Time	Method
Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI)	baseline and 3 months	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 units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L).
Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI)	baseline and 3 months	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 units on an arbitrary scale. SI data is based on a calculation derived from analysis of results of frequently sampled intravenous glucose tolerance test (FSIVGTT) by Bergman et al (doi:10.1172/JCI112886/J Clin Invest. 1987;79(3):790-800) and is reported with units min-1/(µlU/L).

Trial Locations

Locations (1)

General Clinical Research Center; 🇺🇸 Richmond, Virginia, United States