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The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease

NCT00755222 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2017-10-05

Study results available
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Summary

This study evaluated the safety and effectiveness of AA4500 in improving the impact of Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's disease

Conditions

  • Peyronie's Disease

Interventions

BIOLOGICAL

AA4500

2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series was separated by 6 weeks.

BIOLOGICAL

Placebo

2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series is separated by 6 weeks.

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Veronica Urdaneta, MD · Endo Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00755222 on ClinicalTrials.gov