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Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease

NCT02298829 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 184

Last updated 2018-06-20

No results posted yet for this study

Summary

This a Phase 4 non-treatment, long-term follow-up study of subjects who received AA4500 in a 12-month double blind placebo-controlled study (AUX CC 803 or AUX-CC-804) or in a 9-month open label study (AUX-CC-802 or AUX-CC-806) sponsored by Auxilium Pharmaceuticals, Inc. After participation in one of the aforementioned studies, subjects will be followed yearly for up to 4 consecutive long-term follow-up visits with at least 6 months between consecutive visits

Conditions

  • Peyronie's Disease

Interventions

DRUG

Subjects Previously Treated with AA4500

no treatment to be administered - observational only

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-04-09
Completion
2018-04-09

Countries

  • United States

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 NCT02298829 on ClinicalTrials.gov