Metformin in Pregnant PCOS Women

Overview[ - collapse ][ - ]

Purpose 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.
ConditionPolycystic Ovary Syndrome
InterventionDrug: Metformin
Drug: Placebo
PhasePhase 3
SponsorNorwegian University of Science and Technology
Responsible PartyNorwegian University of Science and Technology
ClinicalTrials.gov IdentifierNCT00159536
First ReceivedSeptember 8, 2005
Last UpdatedOctober 28, 2013
Last verifiedOctober 2013

Tracking Information[ + expand ][ + ]

First Received DateSeptember 8, 2005
Last Updated DateOctober 28, 2013
Start DateFebruary 2005
Estimated Primary Completion DateOctober 2009
Current Primary Outcome Measures
  • Gestational diabetes [Time Frame: up to delivery] [Designated as safety issue: No]
  • incidence of metabolic syndrome and neurophysiologic parameters in offspring [Time Frame: Within 18 years] [Designated as safety issue: No]
  • Preterm delivery [Time Frame: up to delivery] [Designated as safety issue: No]
  • pre-eclampsia [Time Frame: up to delivery] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • emesis and hyperemesis [Time Frame: upt to delivery] [Designated as safety issue: No]
  • Breastfeeding [Time Frame: One year post partum] [Designated as safety issue: No]
  • weight change [Time Frame: up to delivery] [Designated as safety issue: No]
  • blood pressure change [Time Frame: up to delivery] [Designated as safety issue: No]
  • Incident of instrumental deliveries [Time Frame: at delivery] [Designated as safety issue: No]
  • Hormone levels in mother and offspring [Time Frame: up to delivery] [Designated as safety issue: No]
  • Snoring and sleep quality [Time Frame: up to delivery] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin in Pregnant PCOS Women
Official TitleMetformin Treatment of Pregnant Women With Polycystic Ovary Syndrome (PCOS)
Brief 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
ConditionPolycystic Ovary Syndrome
InterventionDrug: 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 Names:
metformin from Weifa 500 mg / tabletDrug: 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 Names:
Placebo from Weifa
Study Arm (s)
  • Experimental: Metformin
    Metformin 1000mg x 2 daily
  • Placebo Comparator: placebo
    Placebo x 2 daily

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment257
Estimated Completion DateOctober 2009
Estimated Primary Completion DateOctober 2009
Eligibility Criteria
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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNorway

Administrative Information[ + expand ][ + ]

NCT Number NCT00159536
Other Study ID NumbersPregMet
Has Data Monitoring CommitteeNo
Information Provided ByNorwegian University of Science and Technology
Study SponsorNorwegian University of Science and Technology
CollaboratorsSt. Olavs Hospital
Investigators Principal Investigator: Eszter I Vanky, MD, PhD Norwegian University of Science and Technology
Verification DateOctober 2013

Locations[ + expand ][ + ]

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