Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome
Overview[ - collapse ][ - ]
| Purpose | Insulin resistance is an important feature of the polycystic ovary syndrome,and patiens are successfully treated with the insulin sensitizing agent metformin. The insulin resistance of lean patients with the syndrome is debated. In this study, we will study the change in insulin resistance, metabolic and hormonal factors after 3 months of metformin treatment in lean PCOS women. |
|---|---|
| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin |
| Phase | N/A |
| Sponsor | Skejby Hospital |
| Responsible Party | Aarhus University Hospital Skejby |
| ClinicalTrials.gov Identifier | NCT00319293 |
| First Received | April 26, 2006 |
| Last Updated | October 10, 2006 |
| Last verified | October 2006 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 26, 2006 |
|---|---|
| Last Updated Date | October 10, 2006 |
| Start Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome |
|---|---|
| Official Title | Not Provided |
| Brief Summary | Insulin resistance is an important feature of the polycystic ovary syndrome,and patiens are successfully treated with the insulin sensitizing agent metformin. The insulin resistance of lean patients with the syndrome is debated. In this study, we will study the change in insulin resistance, metabolic and hormonal factors after 3 months of metformin treatment in lean PCOS women. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 20 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - PCOS (Rotterdam criteria) - BMI < 27 - No medication for 3 months Exclusion Criteria: - Pregnancy - Lactation - Other endocrinologic disease |
| Gender | Female |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00319293 |
|---|---|
| Other Study ID Numbers | 160350-2 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Aarhus University Hospital Skejby |
| Study Sponsor | Skejby Hospital |
| Collaborators | Aarhus University Hospital |
| Investigators | Principal Investigator: Birgitta Trolle, MD Skejby University Hospital |
| Verification Date | October 2006 |