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A Study of AA4500 in Men With Peyronie's Disease

NCT01243411 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2017-10-05

Study results available
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Summary

This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle.

After up to four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36).

After the final injection of each treatment cycle, the investigator will model the plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to \<15° after the first, second, or third cycle of injections or if the investigator determines further treatment is not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles will not be administered.

Approximately 300 subjects will be enrolled.

Conditions

  • Peyronie's Disease

Interventions

BIOLOGICAL

AA4500

2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gregory J. Kaufman, MD · Auxilium Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • Denmark
  • France
  • Germany
  • Italy
  • New Zealand
  • Spain
  • Sweden
  • 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 NCT01243411 on ClinicalTrials.gov