The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
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-hospital based populations have provided evidence that the incidence of
hyperandrogenic chronic anovulation is in the range of 4-6% of the female population.
Improvements in insulin sensitivity in women with PCOS, either through lifestyle changes or
through pharmaceutical intervention, have consistently resulted in a marked improvement in
the reproductive and metabolic abnormalities in PCOS. The primary objective in the adult
female population is to determine that combination therapy will improve ovulatory frequency.
Secondary objective is to improve circulating hyperandrogenemia and insulin sensitivity then
single agent therapy. The primary objective of the adolescent population is to determine
that the combination therapy will improve hyperandrogenemia. Secondary objective is to
improve ovulatory frequency and insulin sensitivity than just the use of a single agent
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Change in Testosterone After 6 Months of Treatment
The investigators hypothesize that combination therapy will result in a greater improvement in hyperandrogenemia than single agent therapy.
baseline and 6 months
Richard Legro, M.D.
Milton S. Hershey Medical Center
United States: Food and Drug Administration
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