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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-11-08

No results posted yet for this study

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

BIOLOGICAL

AA4500

DEVICE

ErecAid® Esteem® Manual Vacuum Therapy System

PROCEDURE

Investigator Modeling

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Neil Shusterman, MD · Endo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-10-31
Completion
2016-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02267460 on ClinicalTrials.gov