NCT02267460

An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease

A Phase 3b, Open-label Pilot Study to Evaluate the Safety and Effectiveness of up to Four Treatment Cycles of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Men With Peyronie's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Enrollment will include approximately 30 AA4500 naïve subjects. Subjects will be divided by degree of penile curvature and then randomized in a 1:1 ratio to one of the following treatment groups: * AA4500 with investigator modeling * AA4500 without investigator modeling Each subject will receive 2 injections of AA4500, separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles. Approximately 14 days after the second injection of AA4500, each subject will visit the study site and the investigator will assess the subject and instruct the subject on appropriate use of the ErecAid® Esteem® Manual Vacuum Therapy System.

Conditions

• Peyronie's Disease

Interventions

Type	Name	Description
BIOLOGICAL	AA4500
DEVICE	ErecAid® Esteem® Manual Vacuum Therapy System
PROCEDURE	Investigator Modeling

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-10-01
• Completion: 2016-03-01
• First posted: 2014-10-17
• Last updated: 2017-11-08

Locations

1 site across 1 country: United Kingdom