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Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS) - NCT00682890-23298(Clinical Trial 222518)



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City:  Richmond
State:  
VA
Zip Code: 23298
Conditions: PCOS - Insulin Sensitivity - Cardiovascular Inflammatory Markers
Purpose: 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
Study summary: 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.
Criteria: 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 DVT, pregnancy and lactation.
Study is available at: General Clinical Research Center
Richmond, VA 23298
United States

Primary Contact:
Paulina A Essah, MD
Email: pessah@mcvh-vcu.edu
Phone: 804-828-9697

Secondary Contact:
Paulina A Essah, MD
Email: pessah@mcvh-vcu.edu
Phone: 804-828-9697
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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