Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS)
Overview[ - collapse ][ - ]
| Purpose | The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS |
|---|---|
| Condition | PCOS Insulin Sensitivity Cardiovascular Inflammatory Markers |
| Intervention | Drug: placebo Drug: metformin |
| Phase | Phase 4 |
| Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Responsible Party | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier | NCT00682890 |
| First Received | May 21, 2008 |
| Last Updated | October 28, 2012 |
| Last verified | October 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 21, 2008 |
|---|---|
| Last Updated Date | October 28, 2012 |
| Start Date | November 2005 |
| Estimated Primary Completion Date | March 2009 |
| Current Primary Outcome Measures | Improved insulin sensitivity [Time Frame: 3 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Combination Metformin and Oral Contraception for Polycystic Ovary Syndrome (PCOS) |
|---|---|
| Official Title | Combination Metformin and Oral Contraception for PCOS |
| Brief Summary | The purpose of this research study is to determine if adding Metformin, a drug that reduces insulin resistance, to birth control pills will reduce the risk of developing type 2 diabetes, high blood pressure. high lipid levels and heart disease in women with PCOS |
| Detailed Description | Inclusion criteria: PCOS women between the ages of 18-45,< 8 periods annually, elevated serum free testosterone, normal thyroid function tests and serum prolactin, exclusion of late onset adrenal hyperplasia, acceptable health based on interview and medical history, physical exam and lab tests, ability to comply with the requirements of the study and to provide signed, witnessed informed consent. |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention |
| Condition |
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| Intervention | Drug: placebo placebo birth control pill daily Drug: metformin 2000 mg per day for 3 months daily birth control pill |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 6 |
| Estimated Completion Date | March 2009 |
| Estimated Primary Completion Date | December 2008 |
| Eligibility Criteria | Inclusion Criteria: - Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia Exclusion Criteria: - Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of DVT, pregnancy and lactation. |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00682890 |
|---|---|
| Other Study ID Numbers | R03HD47298 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Study Sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Collaborators | Not Provided |
| Investigators | Study Director: Leo Dunn, MD DSMB |
| Verification Date | October 2012 |
Locations[ + expand ][ + ]
| General Clinical Research Center | Richmond, Virginia, United States, 23298 |
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