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

Norwegian University of Science and Technology

Status and phase: Completed; Phase 2

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03259919

220800

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Metformin

Experimental group

Description:

Metformin 850 mg x 2 daily

Treatment:

Drug: Metformin

placebo

Placebo Comparator group

Description:

Placebo 1 tablet x 2 daily

Treatment:

Drug: Placebo