CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 43 enrolled
Drug / intervention
Metformin +3 moredrug
Likely dose
Metformin 425mgfrom 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/NCT00714233
NCT00714233Phase 3Completed
CompareCT.gov

Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents

University of Rochester·interventional·Posted Jul 14, 2008·Updated May 15, 2015

In Brief

A Phase 3 clinical trial evaluating Metformin, Oral Contraceptive Pills (Yasmin), and 2 other interventions for Polycystic Ovary Syndrome. Completed, enrolled 43 participants.

Detailed Summary

A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to: 1. reduce fasting glucose levels 2. reduce androgen hormone levels 3. improve sex steroid binding, and 4. improve lipids (fatty substances in the blood)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2008
Enrollment StartAug 1, 2002
Primary CompletionApr 1, 2004
Study CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 18.0 years ago

Interventions

Metformindrug

Metformin 425mg. capsules, 2 capsules BID x 24 weeks

Oral Contraceptive Pills (Yasmin)drug

Yasmin oral contraceptive tabs; 1 tab daily x 24 weeks

Lifestyle Modificationbehavioral

weekly classes x 24 weeks for training in diet, exercise and behavior modification skills

placebodrug

placebo to the active metformin arm. 2 capsules BID x 24 weeks.