Who is sponsoring OWL-PCOS?

OWL-PCOS is sponsored by Milton S. Hershey Medical Center.

What condition does OWL-PCOS study?

OWL-PCOS studies Polycystic Ovary Syndrome.

What drugs are being tested in OWL-PCOS?

Interventions: Orlistat/Meal Replacement/Lifestyle Modification, Loestrin 1/20, Combination of treatments.

What is the status of OWL-PCOS?

OWL-PCOS is currently COMPLETED.

Last reviewed 2016-11-03 · How we verify

Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women (OWL-PCOS)

NCT00704912 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Milton S. Hershey Medical Center
Phase	Phase 2
Status	COMPLETED
Enrolment	217
Start date	2008-09
Completion	2014-03

Conditions

Polycystic Ovary Syndrome

Interventions

Orlistat/Meal Replacement/Lifestyle Modification
Loestrin 1/20
Combination of treatments

Primary outcomes

Live Birth Rate — Participants were followed for 4 months of attempted conception and those who conceived were then followed for the duration of their pregnancy, approximately 9 months.

Countries

United States