Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Collaborator: St. Olavs Hospital
• Treatments: Metformin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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