Skip to main content
OpenTrials
Completed

NCT Number: NCT02298829

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peyronie's Disease Airway Obstruction Connective Tissue Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Penile Induration Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

18 year–90 year

Sex eligibility

Male

Study type

Observational

Primary location

Alaska Clinical Research Center, LLC, Anchorage, Alaska, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Be able and willing to comply with the follow-up assessments outlined in the protocol, as determined by the investigator.
  • Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).

-

Exclusion criteria

None

-

Treatment and study plan

Subjects Previously Treated with AA4500

Drug

no treatment to be administered - observational only

Primary outcomes

  1. To assess the long-term safety of AA4500 in adult men with Peyronies disease

    Time frame: 5 years post treatment

Secondary outcomes

  1. To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500

    Time frame: 5 years post treatment

Other outcomes

  1. To assess the long-term immunogenicity profile of AA4500 in adult men with Peyronies disease

    Time frame: 5 years post treatment

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2014
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.