At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 40 enrolled

Drug / intervention

Metformin +1 moredrug

Likely dose

Metformin 850 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03259919

NCT03259919Phase 2Completed

Compare CT.gov

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

Norwegian University of Science and Technology·interventional·Posted Aug 24, 2017·Updated Oct 18, 2018

In Brief

A Phase 2 clinical trial evaluating Metformin and Placebo for Polycystic Ovary Syndrome. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPolycystic Ovary Syndrome

CountriesNorway

CollaboratorsSt. Olavs Hospital

Timeline

Phase 2CompletedFinished

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 2000

Primary CompletionMar 2003

First PostedAug 2017

TodayJul 2026

First PostedAug 24, 2017

Enrollment StartOct 1, 2000

Primary CompletionMar 1, 2003

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 8.9 years ago

Interventions

Metformindrug

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.

Placebodrug

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.