At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 30 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 750 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.
Clinical Metabolic and Endocrine Parameters in Response to Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome: A Phase 4 Randomized, Double- Blind and Placebo Control Trial
In Brief
A Phase 4 clinical trial evaluating Metformin and Placebo for Polycystic Ovary Syndrome. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Polycystic ovary syndrome is a frequent cause of abnormal menses and infertility. It has also been related to cardiovascular disease. The objective of this trial is to evaluate the clinical and metabolic efficacy of metformin plus life style modifications in women with polycystic ovary syndrome compared with life style modifications and placebo
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome
CountriesArgentina
Collaborators--
Timeline
Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2003
Primary CompletionSep 2005
Study CompletionDec 2005
First PostedMay 2008
TodayJul 2026
First PostedMay 19, 2008
Enrollment StartJan 1, 2003
Primary CompletionSep 1, 2005
Study CompletionDec 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.1 years ago
Interventions
Metformindrug
Metformin 750 mg BID for 4 months
Placebodrug
Diet counseling and exercise