NCT00755222

The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease

A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Two Times a Week for Up to Three Treatment Cycles (2 x 3) in Subjects With Peyronie's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the safety and effectiveness of AA4500 in improving the impact of Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's disease

Detailed description

A Phase 2b randomized, double-blind, placebo-controlled study of AA4500 in the treatment of subjects with Peyronie's disease. During the screening period, subjects had a physical examination including body weight and height, vital sign measurements, a 12-lead electrocardiogram (ECG), and clinical laboratory testing. Medical history, prior and concomitant medications, and demographic data were recorded.

Conditions

• Peyronie's Disease

Interventions

Type	Name	Description
BIOLOGICAL	AA4500	2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series was separated by 6 weeks.
BIOLOGICAL	Placebo	2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series is separated by 6 weeks.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-09-18
• Last updated: 2017-10-05
• Results posted: 2011-04-26

Locations

12 sites across 1 country: United States