418
Participants
Start Date
October 31, 2010
Primary Completion Date
March 31, 2012
Study Completion Date
March 31, 2012
AA4500
2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
Placebo
2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
University Urology Associates, New York
Michael A. Werner, MD, PC, Purchase
Bruce R. Gilbert, MD, PhD, PC, Great Neck
The Capital Region Medical Research Foundation @ the Urological Institute of Northeastern New York, Albany
Chesapeake Urology Research Assoc., Glen Burnie
Chesapeake Urology Research Assoc., PA, Towson
Universitiy of North Carolina School of Medicine Div. of Urology, Chapel Hill
Duke University Medical Center Division of Urologic Surgery, Durham
Winter Park Urology Associates, Orlando
South Florida Medical Research, Aventura
Costal Clinical Research, Inc., Mobile
Northeast Indiana Research, LLC, Fort Wayne
Metropolitan Urology, P.S.C., Jeffersonville
University of Michigan, Ann Arbor
Kansas City Urology Care, P.A. Research Department, Overland Park
Tulane University Health Sciences Center Dept. of Urology, New Orleans
Regional Urology L.L.C., Shreveport
Research Across America, Carrollton
Urology Clinics of North Texas, PA, Dallas
Urology San Antonio Research, PA, San Antonio
The Urology Center of Colorado, Denver
Idaho Urologic Institute, Meridian
Connect Clinical Research Center (CCRC), Phoenix
So. Orange County Medical Research Center, Laguna Hills
Alaska Clinical Research Center, LLC, Anchorage
Connecticut Clinical Resarch Center, LLC, Middlebury
Cooper Health System, Camden
AdvanceMed Research, Lawrenceville
The Miriam Hospital, Providence
Urology Sydney, Kogarah
Health Pac Medical Centre, Sydney
AusTrials Pty Limited, Brisbane
Bayside Urology, Mentone
Keogh Institute for Medical Research, Nedlands
Lead Sponsor
Endo Pharmaceuticals
INDUSTRY