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Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women

NCT00704912 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2016-11-07

Study results available
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Summary

The goal of this three-armed randomized controlled trial is to establish the relative roles of treatment of hyperandrogenism versus obesity (as the largest modifiable factor contributing to insulin resistance) in treating infertility and improving pregnancy outcomes among obese PCOS women. The investigators hypothesize that the key to restoring ovulation leading to live birth is to correct hyperandrogenism with oral contraceptive pills, but the key to avoiding later pregnancy complications is to improve insulin sensitivity with weight loss.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Orlistat/Meal Replacement/Lifestyle Modification

Orlistat will be given at 60 mg three times per day (1 tablet 3 times a day) before meals, i.e., breakfast, lunch, and dinner.

DRUG

Loestrin 1/20

Patients will be started on a low dose containing OCP for a continuous 4 month period.

DRUG

Combination of treatments

Medications will be administered as described for the other 2 arms.

Sponsors & Collaborators

Principal Investigators

  • Richard S Legro, M.D. · Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

  • Christos Coutifaris, M.D., Ph.D. · Universtiy of Pennsylvania, Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00704912 on ClinicalTrials.gov