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Metabolic Syndrome in PCOS: Precursors and Interventions

NCT00442689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2014-06-06

Study results available
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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.

Conditions

  • Polycystic Ovary Syndrome
  • Metabolic Syndrome

Interventions

DRUG

flutamide

250 mg twice daily

DRUG

ethinyl estradiol 35 mcg and drospirenone 3 mg

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

OTHER

placebo

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Northwestern University

    lead OTHER

Principal Investigators

  • Andrea Dunaif, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00442689 on ClinicalTrials.gov