Status:
COMPLETED
Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
12-39 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if the combination therapy of lifestyle intervention and use of Metformin together will improve ovulation induction and hyperandrogenemia in women with polycy...
Detailed Description
PCOS is characterized by excess circulating androgen levels and chronic anovulation. PCOS is also characterized by insulin resistance and hyperinsulinemia. Several recent studies in a variety of non-h...
Eligibility Criteria
Inclusion
- Spontaneous intermenstrual periods of greater than or equal to 45 days or a total of 8 or less periods per year
- Elevated testosterone levels
- General good health
- Off of current medications which may confound response to study medications
Exclusion
- Pregnancy
- Lactose Intolerance
- Medical Contraindications
- Elevated Prolactin, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests
- Diabetes, liver, heart, kidney or uncorrected thyroid disease
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00151411
Start Date
October 1 2004
End Date
March 1 2008
Last Update
March 21 2018
Active Locations (1)
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1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033