Study of AA4500 in the Treatment of Peyronie's Disease

Status Completed

Clinical Trial Summary

This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 400 (267 AA4500 and 133 placebo) men will be randomized. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle.

Before dosing, subjects will be stratified by degree of penile curvature deformity (ie, 30º to 60º or 61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio either AA4500 0.58 mg or placebo.

In this study, qualified subjects may receive up to four treatment cycles; each cycle will be separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will receive two injections of study drug with at least 24 hours but not more than 72 hours between injections. After the final injection of each treatment cycle, the investigator or qualified designee will model the penile plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to <15 degrees after the first, second, or third cycle of injections or if further treatment is not clinically indicated, subsequent treatment cycles will not be administered.

Following the maximum of four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365 (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive open-label AA4500 treatment after completing this study as part of another protocol.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01221597
Study type	Interventional
Source	Endo Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	September 2010
Completion date	April 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01685437` - A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease	Phase 3
Completed	`NCT01430169` - Pharmacokinetics of a Single Treatment Cycle of AA4500 0.58 mg in Men With Peyronie's Disease	Phase 2
Recruiting	`NCT05108558` - Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders	Phase 4
Recruiting	`NCT05147779` - Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Peyronie's Disease, ED, and Interstitial Cystitis	Phase 1
Recruiting	`NCT03767452` - Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response	Phase 4
Completed	`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	Phase 3
Completed	`NCT01221623` - Study of AA4500 in the Treatment of Peyronie's Disease	Phase 3
Completed	`NCT02298829` - Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease
Completed	`NCT01243411` - A Study of AA4500 in Men With Peyronie's Disease	Phase 3
Completed	`NCT01578473` - Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's Disease	Phase 1
Not yet recruiting	`NCT05855070` - Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease	N/A
Completed	`NCT02072018` - Peyronie's Disease Treatment Protocol	Phase 1
Terminated	`NCT05873595` - Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease
Active, not recruiting	`NCT04786106` - Investigation of Surgery, Collagenase, and Restorex for the Improvement of Peyronie's	Phase 4
Completed	`NCT00812838` - H-22411: BOTOX® for Peyronie's Disease	Phase 2
Completed	`NCT02395029` - Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of PD	Phase 1
Completed	`NCT00755222` - The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease	Phase 2