CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 65 enrolled
Drug / intervention
rosiglitazone +1 moredrug
Likely dose
rosiglitazone 4 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/NCT00640224
NCT00640224Phase 4Completed
CompareCT.gov

Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives

Silva Arslanian·interventional·Posted Mar 21, 2008·Updated Nov 17, 2017

In Brief

A Phase 4 clinical trial evaluating rosiglitazone and drospirenone/ethinyl estradiol for Polycystic Ovary Syndrome. Completed, enrolled 65 participants across 1 site.

Detailed Summary

The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2008
Enrollment StartMar 1, 2005
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 18.3 years ago

Interventions

rosiglitazonedrug

4 mg daily for 6 months

drospirenone/ethinyl estradioldrug

1 tab (3mg/30mcg) daily for 6 months