Status:
COMPLETED
Metformin in Pregnant PCOS Women
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00159536
Start Date
February 1 2005
End Date
October 1 2009
Last Update
February 15 2019
Active Locations (10)
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1
Ålesund Hospital
Ålesund, Norway
2
University hospital of Bergen
Bergen, Norway
3
Central Hospital of Northern Norway
Bodø, Norway
4
Buskerud Hospital
Drammen, Norway