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Metformin in Pregnant PCOS Women (PregMet)

This study has been completed.
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology Identifier:
First received: September 8, 2005
Last updated: May 23, 2014
Last verified: May 2014
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.

Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)

Resource links provided by NLM:

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Gestational diabetes [ Time Frame: up to delivery ]
  • incidence of metabolic syndrome and neurophysiologic parameters in offspring [ Time Frame: Within 18 years ]
  • Preterm delivery [ Time Frame: up to delivery ]
  • pre-eclampsia [ Time Frame: up to delivery ]

Secondary Outcome Measures:
  • emesis and hyperemesis [ Time Frame: up to delivery ]
  • Breastfeeding [ Time Frame: One year post partum ]
  • weight change [ Time Frame: up to delivery ]
  • blood pressure change [ Time Frame: up to delivery ]
  • Incident of instrumental deliveries [ Time Frame: at delivery ]
  • Hormone levels in mother and offspring [ Time Frame: up to delivery ]
  • Snoring and sleep quality [ Time Frame: up to delivery ]

Enrollment: 257
Study Start Date: February 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Metformin 1000mg x 2 daily
Drug: Metformin
Metformin 1000 mg x 2 per day. Orally. From inclusion (before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
Other Name: metformin from Weifa 500 mg / tablet
Placebo Comparator: placebo
Placebo x 2 daily
Drug: Placebo
Placebo, 2 tablets x 2 daily.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study
Other Name: Placebo from Weifa


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18-45 years,
  • PCOS diagnosis according to Rotterdam criteria
  • single, viable, ultrasound verified fetus
  • if metformin was used at conception and early pregnancy, at least 7 days of "wash out"

Exclusion Criteria:

  • known liver disease or ALAT > 90 nmol/L
  • known renal disease or creatinine > 110 micromol/L
  • diabetes mellitus
  • alcohol or drug abuse
  • peroral steroid treatment
  • cimetidine, anticoagulant or erythromycin treatment at time of inclusion
  • not suitable for other reasons
  Contacts and Locations
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Please refer to this study by its identifier: NCT00159536

University hospital of Bergen
Bergen, Norway
Central Hospital of Northern Norway
Bodø, Norway
Buskerud Hospital
Drammen, Norway
Haugesund Hospital
Haugesund, Norway
Ringerike Hospital
Hønefoss, Norway
Elvebredden Gynekologpraksis
Kristiansand, Norway
Lillehammer Hospital
Lillehammer, Norway
Stavanger University Hospital
Stavanger, Norway
Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital
Trondheim, Norway
Ålesund Hospital
Ålesund, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Eszter I Vanky, MD, PhD Norwegian University of Science and Technology
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Norwegian University of Science and Technology Identifier: NCT00159536     History of Changes
Other Study ID Numbers: PregMet
Study First Received: September 8, 2005
Last Updated: May 23, 2014

Keywords provided by Norwegian University of Science and Technology:
preterm delivery

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 27, 2017