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

Official Title: “The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: Metformin
  • Medication was initiated in a step-up fashion every five days, from one tablet per day to four (500 mg per tablet).
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Metformin
  • Metformin
• Placebo Comparator: Placebo
  • Placebo

Primary Measures

• Change in Testosterone After 6 Months of Treatment
  • Time Frame: baseline and 6 months
    Safety Issue?: No

Secondary Measures

• The Investigators Hypothesize That Combination Therapy Will Result in a Greater Improvement in Ovulatory Frequency and Insulin Sensitivity That Single Agent Therapy.
  • Time Frame: baseline and monthly, up to six months post-randomization
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 39 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Penn State University Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151411

Study ID Number: 2003-172

ClinicalTrials.gov Identifier: NCT00151411

Health Authority: United States: Food and Drug Administration

Click here for more information about this study