Status:
COMPLETED
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
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
- diagnosis polycystic ovary syndrome (PCOS ) before pregnancy
- BMI 27-40 kg/m2
- Human chorionic gonadotropin, beta subunit (HCG-beta) verified pregnancy week 5-8
- At least one of the following criteria: (1) serum testosteron \> 2,5 nmol/L; (2) Sex hormone binding globulin (SHBG) \< 30 nmol; (3) Fasting C-peptid \> 1,0 nmol/L; (4) Menstrual disturbances: oligo-/amenorrhea or metrorrhagia; (5) Hirsutism
Exclusion
- known liver disease or ALAT \> 60 IU/L
- S-creatinin \> 130 micromol/L
- diabetes mellitus
- alcohol or drug abuse
- peroral steroid treatment (except inhalation steroids)
- use of cimetidine, anticoagulant, erythromycin or other macrolides
- not suitable for other reasons
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03259919
Start Date
October 1 2000
End Date
March 1 2003
Last Update
October 18 2018
Active Locations (1)
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1
Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital
Trondheim, Norway