At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 326 enrolled

Drug / intervention

metformindrug

Likely dose

metformin 2gfrom 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/NCT00994812

NCT00994812Phase 3Completed

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Effects of Metformin on Fertility and Pregnancy in Women With Polycystic Ovary Syndrome: a Randomized, Prospective, Placebo-controlled Multicenter Study

University of Oulu·interventional·Posted Oct 14, 2009·Updated Feb 23, 2010

In Brief

A Phase 3 clinical trial evaluating metformin for Polycystic Ovary Syndrome and 4 related conditions. Completed, enrolled 326 participants across 5 sites.

Detailed Summary

The purpose of this study is to determine whether metformin may improve pregnancy rates, and decrease miscarriage rates and complications of pregnancy, such as toxemia and gestational diabetes, in women with polycystic ovary syndrome (PCOS).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPolycystic Ovary Syndrome, Miscarriage, Infertility, Toxemia, Gestational Diabetes

CountriesFinland

CollaboratorsUniversity of Eastern Finland, University of Helsinki, Tampere University, University of Turku

Timeline

Phase 3CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2002

First PostedOct 2009

Primary CompletionDec 2009

TodayJul 2026

First PostedOct 14, 2009

Enrollment StartAug 1, 2002

Primary CompletionDec 1, 2009

TodayJul 2, 2026

Enrollment to primary: 7.3 yearsPosted 16.7 years ago

Interventions

metformindrug

The obese women will be randomized either to metformin (2g/day) or to placebo, and the non-obese either to metformin (1.5g/day) or to placebo. All subjects will be evaluated 1 to 7 days after spontaneous menstruation (oligomenorrheic patients), or at any other convenient time (amenorrheic subjects). After the treatment of 3 months with metformin/placebo alone, another appropriate infertility treatment will be combined with metformin/placebo (clomiphene, ovulation induction, insemination or in vitro fertilization) if no pregnancy has occurred. This treatment will be continued another 6 months' period. If pregnancy occurs, subjects will be re-examined at 7-8 weeks of gestation.