Metformin in Pregnant PCOS Women
Overview[ - collapse ][ - ]
Purpose | To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome. |
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Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Metformin Drug: Placebo |
Phase | Phase 3 |
Sponsor | Norwegian University of Science and Technology |
Responsible Party | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier | NCT00159536 |
First Received | September 8, 2005 |
Last Updated | October 28, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | September 8, 2005 |
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Last Updated Date | October 28, 2013 |
Start Date | February 2005 |
Estimated Primary Completion Date | October 2009 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Metformin in Pregnant PCOS Women |
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Official Title | Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS) |
Brief Summary | To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Metformin Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study Other Names: metformin from Weifa 500 mg / tabletDrug: Placebo Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study Other Names: Placebo from Weifa |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 257 |
Estimated Completion Date | October 2009 |
Estimated Primary Completion Date | October 2009 |
Eligibility Criteria | Inclusion Criteria: - 18-45 years, - PCOS diagnosis according to Rotterdam criteria - single, viable, ultrasound verified fetus - if metformin was used at conception and early pregnancy, at least 7 days of "wash out" Exclusion Criteria: - known liver disease or ALAT > 90 nmol/L - known renal disease or creatinine > 110 micromol/L - diabetes mellitus - alcohol or drug abuse - peroral steroid treatment - cimetidine, anticoagulant or erythromycin treatment at time of inclusion - not suitable for other reasons |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Norway |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00159536 |
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Other Study ID Numbers | PregMet |
Has Data Monitoring Committee | No |
Information Provided By | Norwegian University of Science and Technology |
Study Sponsor | Norwegian University of Science and Technology |
Collaborators | St. Olavs Hospital |
Investigators | Principal Investigator: Eszter I Vanky, MD, PhD Norwegian University of Science and Technology |
Verification Date | October 2013 |
Locations[ + expand ][ + ]
University hospital of Bergen | Bergen, Norway |
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Central Hospital of Northern Norway | Bodø, Norway |
Buskerud Hospital | Drammen, Norway |
Haugesund Hospital | Haugesund, Norway |
Ringerike Hospital | Hønefoss, Norway |
Elvebredden Gynekologpraksis | Kristiansand, Norway |
Lillehammer Hospital | Lillehammer, Norway |
Stavanger University Hospital | Stavanger, Norway |
Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital | Trondheim, Norway |
Ålesund Hospital | Ålesund, Norway |