Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin Drug: Placebo |
| Phase | Phase 2 |
| Sponsor | Milton S. Hershey Medical Center |
| Responsible Party | Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier | NCT00151411 |
| First Received | September 8, 2005 |
| Last Updated | December 20, 2012 |
| Last verified | December 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 8, 2005 |
|---|---|
| Last Updated Date | December 20, 2012 |
| Start Date | October 2004 |
| Estimated Primary Completion Date | March 2008 |
| Current Primary Outcome Measures | Change in Testosterone After 6 Months of Treatment [Time Frame: baseline and 6 months] [Designated as safety issue: No]The investigators hypothesize that combination therapy will result in a greater improvement in hyperandrogenemia than single agent therapy. |
| Current Secondary Outcome 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] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS) |
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| Official Title | The Effect of Combination Therapy With Lifestyle Intervention and Metformin in Females With Polycystic Ovary Syndrome |
| 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 Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition | Polycystic Ovary Syndrome |
| Intervention | 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 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 114 |
| Estimated Completion Date | March 2008 |
| Estimated Primary Completion Date | March 2008 |
| 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 |
| Gender | Female |
| Ages | 12 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00151411 |
|---|---|
| Other Study ID Numbers | 2003-172 |
| Has Data Monitoring Committee | No |
| Information Provided By | Milton S. Hershey Medical Center |
| Study Sponsor | Milton S. Hershey Medical Center |
| Collaborators | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Investigators | Principal Investigator: Richard Legro, M.D. Milton S. Hershey Medical Center |
| Verification Date | December 2012 |
Locations[ + expand ][ + ]
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania, United States, 17033 |
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