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

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Placebo; Drug: Metformin; Behavioral: Lifestyle Intervention

• Registration Number: NCT00151411
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2011-06-07
• Results First Submitted QC: 2011-10-03
• Results First Posted: 2011-11-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-19
• Last Update Posted: 2018-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Lifestyle Intervention	Metformin
Placebo	Placebo	Placebo
Placebo	Lifestyle Intervention	Placebo
Metformin	Metformin	Metformin

Primary Outcome Measures

Name	Time	Method
Change in Testosterone After 6 Months of Treatment	baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
Ovulation Rate	6 months	Count of ovulations per subject during the treatment period.
Change in Insulin Sensitivity Index After 6 Months of Treatment	baseline and 6 months

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States