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

NCT02267460 | Completed Phase 3

• 1 other identifier: AUX-CC-807
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

Peyronie's disease; penile plaque; penile curvature

Outcome Measures

Primary Outcomes (1)

• Percent in improvement from baseline in penile curvature

  measurement of erect penis at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)

  36 Weeks

Secondary Outcomes (7)

• Change in Peyronies disease bother

  36 Weeks

• Change in Peyronies disease physical symptoms

  Week 36

• Change in Peyronies disease psychological symptoms

  36 Weeks

• Change in penile plaque consistency

  36 Weeks

• Change in penile length

  36 Weeks

Study Arms (2)

AA4500 with investigator modeling and vacuum therapy

ACTIVE COMPARATOR

AA4500 with investigator modeling and home use of the ErecAid® Esteem® Manual Vacuum Therapy System.

Biological: AA4500; Device: ErecAid® Esteem® Manual Vacuum Therapy System; Procedure: Investigator Modeling

AA4500 without investigator modeling/with vacuum therapy

ACTIVE COMPARATOR

AA4500 without investigator modeling but with home use of the ErecAid® Esteem® Manual Vacuum Therapy System.

Biological: AA4500; Device: ErecAid® Esteem® Manual Vacuum Therapy System

Interventions

AA4500 BIOLOGICAL

Also known as: Xiaflex, Xiapex, collagenase clostridium histolyticum

AA4500 with investigator modeling and vacuum therapy; AA4500 without investigator modeling/with vacuum therapy

ErecAid® Esteem® Manual Vacuum Therapy System DEVICE

AA4500 with investigator modeling and vacuum therapy; AA4500 without investigator modeling/with vacuum therapy

Investigator Modeling PROCEDURE

AA4500 with investigator modeling and vacuum therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a male ≥ 18 years of age
• Have symptom(s) of Peyronie's disease and have evidence of stable disease as determined by the investigator
• Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the single plane of maximal curvature for evaluation during the study
• Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile
• Voluntarily sign and date an informed consent agreement approved by the Independent Ethics Committee (IEC).
• Be able to read, complete and understand the various rating instruments in English.

You may not qualify if:

• Has a penile curvature of less than 30° or greater than 90° at the screening visit
• Has any of the following conditions:
• Chordee in the presence or absence of hypospadias
• Thrombosis of the dorsal penile artery and/or vein
• Infiltration by a benign or malignant mass resulting in penile curvature
• Infiltration by an infectious agent, such as lymphogranuloma venereum
• Ventral curvature from any cause
• Presence of an active sexually transmitted disease
• Known active hepatitis B or C
• Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
• Has a history of spontaneous priapism (ie, erection that lasts more than four hours)
• Has previously undergone surgery for Peyronie's disease
• Fails to have an erection which, in the opinion of the investigator, is sufficient to accurately measure the subject's penile deformity after administration of prostaglandin E1
• Has an isolated hourglass deformity of the penis
• Has the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would interfere with the injection of AA4500 into the plaque

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (1)

Hospital of St John and St Elizabeth

London, NW8 9NH, United Kingdom

Location

Related Publications (1)

• Ralph DJ, Abdel Raheem A, Liu G. Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study. J Sex Med. 2017 Nov;14(11):1430-1437. doi: 10.1016/j.jsxm.2017.08.015. Epub 2017 Sep 30.

  PMID: 28974406 DERIVED

MeSH Terms

Conditions

Penile Induration

Interventions

Microbial Collagenase; xiapex

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Neil Shusterman, MD

  Endo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 17, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: March 1, 2016
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

GB (1)