At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women
In Brief
A Phase 2 clinical trial evaluating Orlistat/Meal Replacement/Lifestyle Modification, Loestrin 1/20, and 1 other intervention for Polycystic Ovary Syndrome. Completed, enrolled 217 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
Patients will be started on a low dose containing OCP for a continuous 4 month period.
Medications will be administered as described for the other 2 arms.