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.

Condition	Intervention	Phase
Polycystic Ovary Syndrome	Drug: Metformin	Phase II

Further Study Details: 

Primary Outcomes: We hypothesize that combination therapy will result in a greater improvement in hyperandrogenemia that single agent therapy.
Secondary Outcomes: We hypothesize that combination therapy will result in a greater improvement in ovulatory frequency and insulin sensitivity that single agent therapy.
Expected Total Enrollment:  150

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.

Ages Eligible for Study:  12 Years   -   39 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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, 17 OHP, or FSH blood tests
• Diabetes, liver, heart, kidney or uncorrected thyroid disease

Please refer to this study by ClinicalTrials.gov identifier  NCT00151411

Patsy Rawa, B.S.      717-531-3692    prawa@psu.edu
Sandy Eyer      717-531-1540    seyer@psu.edu

Pennsylvania
      Penn State Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  2003-172; HD-02-012
Last Updated:  September 8, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00151411
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13