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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2003-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metformin

Metformin 850 mg x 2 daily

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin 850 mg x 1 per day for the first week, and 850 mg x 2 per day for the rest of the study period.. Orally. From inclusion (before gestational week 8) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.

placebo

Placebo 1 tablet x 2 daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, 2 tablets x 1 daily for the first week, and 2 tablets x 2 for the rest of the study period.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.

Interventions

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Metformin

Metformin 850 mg x 1 per day for the first week, and 850 mg x 2 per day for the rest of the study period.. Orally. From inclusion (before gestational week 8) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.

Intervention Type DRUG

Placebo

Placebo, 2 tablets x 1 daily for the first week, and 2 tablets x 2 for the rest of the study period.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.

Intervention Type DRUG

Other Intervention Names

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metformin from Weifa 425 mg / tablet Placebo from Weifa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No