CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 97 enrolled
Drug / intervention
flutamide +2 moredrug
Likely dose
ethinyl estradiol 35 mcg and drospirenone 3 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/NCT00442689
NCT00442689N/ACompleted
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Metabolic Syndrome in PCOS: Precursors and Interventions

Northwestern University·interventional·Posted Mar 2, 2007·Updated Jun 6, 2014

In Brief

A clinical study evaluating flutamide, ethinyl estradiol 35 mcg and drospirenone 3 mg, and 1 other intervention for Polycystic Ovary Syndrome and Metabolic Syndrome. Completed, enrolled 97 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome, Metabolic Syndrome
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2, 2007
Enrollment StartJul 1, 2006
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 19.3 years ago

Interventions

flutamidedrug

250 mg twice daily

ethinyl estradiol 35 mcg and drospirenone 3 mgdrug

one active pill per day for three weeks and then 1 sugar pill per day for one week

placeboother