418
Participants
Start Date
September 30, 2010
Primary Completion Date
April 30, 2012
Study Completion Date
April 30, 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.
Division of Urology at Maimonides Medical Center, Brooklyn
Urological Associates of Lancaster, Lancaster
Urology Health Specialists,LLC, Bryn Mawr
Chesapeake Urology Research Associates, Baltimore
Johns Hopkins Hospital, Baltimore
Urology of Virginia - Sentara Medical Group, Norfolk
Alliance Urology Specialists, PA, Greensboro
Wake Urological Associates, Raleigh
Southeastern Medical Research Institute, Columbus
Palm Beach Urology Associates, Wellington
DCT-Celebration, LLC dba Discovery Clinical Trials, Celebration
Urology Centers of Alabama, PC, Homewood
Alpha Clinical Research, LLC, Clarksville
Tristate Urologic Services PSC Inc. dba TUG Research, Cincinnati
Urology of Indiana LLC, Avon
Medical College of Wisconsin, Department of Urology, Milwaukee
Mayo Clinic at Rochester, Dept. of Urology, Rochester
DuPage Medical Group, Downers Grove
Urology Associates of North Texas, Arlington
Baylor College of Medicine, Department of Urology, Houston
Salt Lake Research, PLLC, Salt Lake City
HOPE Research Institute, LLC, Phoenix
Urology Associates Medical Group, Burbank
San Diego Sexual Medicine, San Diego
California Professional Research, Newport Beach
Grove Hill Clinical Research, Grove Hill Medical Center, New Britain
The Urology Center, PC, New Haven
Mens Health Boston, Brookline
Center for Reproductive Medicine, Hackensack
Australian Centre for Sexual Health, St Leonards
Western Urology, Westmead
AusTrials, Kipparing
Repatriation General Hospital, Daws Park
Australian Urology Associates Pty Ltd, Malvern
Lead Sponsor
Endo Pharmaceuticals
INDUSTRY