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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease in Studies AUX-CC-802

Brief 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

Detailed Summary:

At each long-term follow-up visit, subjects will be assessed for adverse events relative to their previous long-term follow-up assessment. Blood samples for the determination of antibodies to AUX-I and AUX-II and neutralizing antibodies to AUX-I and AUX-II will be collected at each long-term follow-up visit.

At each long-term follow-up visit, a flaccid penile examination will be performed and a curvature deformity measurement (with the penis in the erect state) will be recorded. Subjects will also be asked to complete the Peyronie's Disease Questionnaire (PDQ) and the International Index of Erectile Function (IIEF) questionnaire. At each visit, medical, surgical, or other treatments for Peyronie's disease since the last assessment will also be collected and recorded.

Sponsor: Endo Pharmaceuticals

Current Primary Outcome: To assess the long-term safety of AA4500 in adult men with Peyronies disease [ Time Frame: 5 years post treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500 [ Time Frame: 5 years post treatment ]

Original Secondary Outcome: Same as current

Information By: Endo Pharmaceuticals

Dates:
Date Received: November 20, 2014
Date Started: November 2014
Date Completion: September 2018
Last Updated: October 24, 2016
Last Verified: October 2016