Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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:
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.