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

N

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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