Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (PCOS) Women (OWL-PCOS)
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|ClinicalTrials.gov Identifier: NCT00704912|
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : December 17, 2015
Last Update Posted : November 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Drug: Orlistat/Meal Replacement/Lifestyle Modification Drug: Loestrin 1/20 Drug: Combination of treatments||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||217 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Hyperandrogenism vs. Insulin Resistance in Infertile PCOS Women|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Active Comparator: Lifestyle intervention
Orlistat/Meal Replacement/Lifestyle Modification
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.
Active Comparator: Oral Contraceptives (OCP)
Drug: Loestrin 1/20
Patients will be started on a low dose containing OCP for a continuous 4 month period.
Active Comparator: Lifestyle/OCP Combined
Combination of treatments
Drug: Combination of treatments
Medications will be administered as described for the other 2 arms.
- Live Birth Rate [ Time Frame: 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. ]
- Ovulation Rate [ Time Frame: Up to 4 months ]
- Change in Weight [ Time Frame: Baseline, 4 months ]Change from baseline to end of the 4-month intervention.
- Prevalence of Metabolic Syndrome [ Time Frame: Baseline, 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704912
|United States, Pennsylvania|
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|University of Pennsylvania, Department of Obstetrics and Gynecology|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Richard S Legro, M.D.||Penn State College of Medicine, Penn State Milton S. Hershey Medical Center|
|Principal Investigator:||Christos Coutifaris, M.D., Ph.D.||Universtiy of Pennsylvania, Department of Obstetrics and Gynecology|