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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polycystic Ovary Syndrome, PCOS, Insulin Sensitivity

Intervention / Treatment
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* Drug: placebo
* Drug: metformin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo tablet and birth control pill daily | Drug: placebo<br>* placebo birth control pill daily<br>|
| Active Comparator: 2<br>metformin 2000 mg and birth control pill daily | Drug: metformin<br>* 2000 mg per day for 3 months daily birth control pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insulin Sensitivity Measures: Insulin Sensitivity Index (ISI) | 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). | baseline and 3 months | 
| Change in Insulin Sensitivity Measures: Insulin Sensitivity (SI) | 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). | baseline and 3 months |