Status:
TERMINATED
Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Polycystic Ovary Syndrome
PCOS
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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 pr...
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 hyp...
Eligibility Criteria
Inclusion
- 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
- Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00682890
Start Date
November 1 2005
End Date
January 1 2010
Last Update
August 20 2014
Active Locations (1)
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1
General Clinical Research Center
Richmond, Virginia, United States, 23298