Overview

This trial is active, not recruiting.

Condition peyronie's disease
Treatment subjects previously treated with aa4500
Phase phase 4
Sponsor Endo Pharmaceuticals
Start date November 2014
End date May 2018
Trial size 280 participants
Trial identifier NCT02298829, AUX-CC-810

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
subjects previously treated with aa4500
no treatment to be administered - observational only

Primary Outcomes

Measure
To assess the long-term safety of AA4500 in adult men with Peyronies disease
time frame: 5 years post treatment

Secondary Outcomes

Measure
To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500
time frame: 5 years post treatment

Eligibility Criteria

Male participants from 18 years up to 90 years old.

Inclusion Criteria: 1. Have received at least one injection of AA4500 and completed at least the first or last follow-up visit in one of the Auxilium-sponsored studies (AUX CC-802, AUX-CC-803, AUX-CC-804, or AUX-CC-806). 2. Be able and willing to comply with the follow-up assessments outlined in the protocol, as determined by the investigator. 3. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). Exclusion Criteria:

Additional Information

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, AUX-CC-803, AUX-CC-804 and AUX-CC-806
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Endo Pharmaceuticals.