Combination Metformin and Oral Contraception for PCOS
18 Years
45 Years
Female
PCOS, Insulin Sensitivity, Cardiovascular Inflammatory Markers
Trial Information
Combination Metformin and Oral Contraception for PCOS
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Improved insulin sensitivity
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Leo Dunn, MD
Investigator Role:
Study Director
Investigator Affiliation:
DSMB
Authority:
United States: Federal Government
Study ID:
R03HD47298
NCT ID:
NCT00682890
Start Date:
November 2005
Completion Date:
March 2009
Related Keywords:
- PCOS
- Insulin Sensitivity
- Cardiovascular Inflammatory Markers
- Polycystic Ovary Syndrome
- Insulin Resistance
Name | Location |
|---|---|
| General Clinical Research Center | Richmond, Virginia 23298 |
