Phase 2
N=114
Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
Polycystic Ovary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00151411 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: Change in Testosterone After 6 Months of Treatment — -2.1; -6.4 ng/dL — p=0.54
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Metformin (Drug); Placebo (Drug); Lifestyle Intervention (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Testosterone After 6 Months of Treatment |
-2.1; -6.4 | 0.54 |
| SECONDARY Ovulation Rate |
10; 19; 6; 5; 4; 7 | 0.07 |
| SECONDARY Change in Insulin Sensitivity Index After 6 Months of Treatment |
1.9; -2.7 | 0.05 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00151411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.