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Hershey, Pennsylvania 17033


Purpose:

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 polycystic ovary syndrome, by gathering data from adult and adolescent females.


Study summary:

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 therapy.


Criteria:

Inclusion Criteria: - 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 Criteria: - Pregnancy - Lactose Intolerance - Medical Contraindications - Elevated Prolactin, 17hydroxyprogesterone, or Follicle stimulating hormone blood tests - Diabetes, liver, heart, kidney or uncorrected thyroid disease


NCT ID:

NCT00151411


Primary Contact:

Principal Investigator
Richard Legro, M.D.
Milton S. Hershey Medical Center


Backup Contact:

N/A


Location Contact:

Hershey, Pennsylvania 17033
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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