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

Virginia Commonwealth University (VCU)

Status and phase

Terminated

Phase 4

Conditions

PCOS

Polycystic Ovary Syndrome

Insulin Sensitivity

Treatments

Drug: metformin

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00682890

R03HD047298

Details and patient eligibility

About

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

Full 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.

Enrollment

28 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.