Combination Metformin and Oral Contraception for PCOS


Phase 4
18 Years
45 Years
Not Enrolling
Female
PCOS, Insulin Sensitivity, Cardiovascular Inflammatory Markers

Thank you

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