The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome
Overview
- Phase
- Phase 2
- Intervention
- Metformin
- Conditions
- Polycystic Ovary Syndrome
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Change in Testosterone After 6 Months of Treatment
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 polycystic ovary syndrome, by gathering data from adult and adolescent females.
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-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.
Investigators
Richard S. Legro, M.D.
Professor, Obstetrics and Gynecology and Public Health Sciences
Milton S. Hershey Medical Center
Eligibility 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
Arms & Interventions
Metformin
Metformin
Intervention: Metformin
Metformin
Metformin
Intervention: Lifestyle Intervention
Placebo
Placebo
Intervention: Placebo
Placebo
Placebo
Intervention: Lifestyle Intervention
Outcomes
Primary Outcomes
Change in Testosterone After 6 Months of Treatment
Time Frame: baseline and 6 months
Secondary Outcomes
- Ovulation Rate(6 months)
- Change in Insulin Sensitivity Index After 6 Months of Treatment(baseline and 6 months)