Spots Global Cancer Trial Database for MLE4901 vs. Placebo for the Treatment of PCOS
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Trial Identification
Brief Title: MLE4901 vs. Placebo for the Treatment of PCOS
Official Title: A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)
Study ID: NCT02865915
Conditions
Study Description
Brief Summary: This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS.
Detailed Description: Following a Screening/Wash-out Period of up to 12 weeks, an 8-week Lead-in Period (starting with a progestin challenge) will be used to better characterize the study population. A Treatment Period of 28 weeks' duration will follow the Lead-in Period. Then, an 8-week Follow-up Period (i.e., no study drug) will be used to assess the durability of effects of MLE4901. The study duration will be approximately 48 weeks (11 months) per subject
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hope Research Institute, LLC, Phoenix, Arizona, United States
NEA Baptist Clinic, Jonesboro, Arkansas, United States
Excell Research, Oceanside, California, United States
Clinical Research Consulting, LLC, Milford, Connecticut, United States
Avail Clinical Research, LLC, DeLand, Florida, United States
Health Care Family Rehab & Research Center, Hialeah, Florida, United States
University of Florida (UF), Jacksonville, Florida, United States
Palmetto Professional Research, Miami, Florida, United States
Segal Institute for Clinical Research, North Miami, Florida, United States
Compass Research, LLC, Orlando, Florida, United States
Stedman Clinical Trials, LLC, Tampa, Florida, United States
Atlanta Women's Research Institute, Atlanta, Georgia, United States
Advanced Clinical Research, Boise, Idaho, United States
Womens Health Practice, Champaign, Illinois, United States
GTC Enterprises LLC, Shawnee Mission, Kansas, United States
Montana Health Research Institute, Inc., Billings, Montana, United States
Upstate Clinical Research Associates, Williamsville, New York, United States
PMG Research of Cary, Cary, North Carolina, United States
Rapid Medical Research, Inc., Cleveland, Ohio, United States
Aventiv Research, Inc., Columbus, Ohio, United States
University Hospitals Cleveland Medical Center, Mayfield Heights, Ohio, United States
Clinical Research of Tiffin, Tiffin, Ohio, United States
Main Line Fertility and Reproductive Medicine, Bryn Mawr, Pennsylvania, United States
The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania Perelman Center for Advanced Medicine - Penn Fertility Care, Philadelphia, Pennsylvania, United States
Magnolia OB/GYN Research Center, Myrtle Beach, South Carolina, United States
Texas Diabetes and Endocrinology, P.A. - South Austin, Austin, Texas, United States
Wasatch Clinical Research, Salt Lake City, Utah, United States
Highland Clinical Research, Salt Lake City, Utah, United States
Charlottesville Medical Research Center, LLC, Charlottesville, Virginia, United States
Tidewater Clinical Research, Inc., Norfolk, Virginia, United States
Contact Details
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