Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors
Overview[ - collapse ][ - ]
| Purpose | Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular. Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment. |
|---|---|
| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin |
| Phase | N/A |
| Sponsor | Skejby Hospital |
| Responsible Party | Aarhus University Hospital Skejby |
| ClinicalTrials.gov Identifier | NCT00317928 |
| First Received | April 24, 2006 |
| Last Updated | October 10, 2006 |
| Last verified | August 2001 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 24, 2006 |
|---|---|
| Last Updated Date | October 10, 2006 |
| Start Date | August 2001 |
| Estimated Primary Completion Date | September 2004 |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy of Metformin in PCOS: Metabolic and Hormonal Factors |
|---|---|
| Official Title | Not Provided |
| Brief Summary | Hypothesis: Metformin treatment normalises hormone values and metabolic parameters in women with PCOS. Ovulation is restored and bleeding periods become regular. Fifty women with PCOS (Rotterdam criteria) are randomised to either placebo or metformin for 6 months. After a wash-out period of 3 months, the opposite treatment is given for another 6 months. Measurements are performed before ech treatment period, every second month during treatment and after completing treatment. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Polycystic Ovary Syndrome |
| Intervention | Drug: Metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | September 2004 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Diagnosis of PCOS - Age 20 - 45 Exclusion Criteria:Diabetes - Diabetes - Hormonal treatment - Pregnancy, lactation - Periclimacteric |
| Gender | Female |
| Ages | 20 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00317928 |
|---|---|
| Other Study ID Numbers | 160350-1 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Aarhus University Hospital Skejby |
| Study Sponsor | Skejby Hospital |
| Collaborators | Regional Hospital Holstebro Aarhus University Hospital |
| Investigators | Principal Investigator: Ditte Trolle, MD Skejby University Hospital, Aarhus, Denmark |
| Verification Date | August 2001 |