Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Metformin

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