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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02298829
Other study ID # AUX-CC-810
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2014
Est. completion date April 9, 2018

Study information

Verified date June 2018
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date April 9, 2018
Est. primary completion date April 9, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 90 Years
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Subjects Previously Treated with AA4500
no treatment to be administered - observational only

Locations

Country Name City State
United States Community Care Physicians, PC Albany New York
United States Alaska Clinical Research Center, LLC Anchorage Alaska
United States South Florida Medical Research Aventura Florida
United States Urology of Indiana LLC Avon Indiana
United States Urologic Consultants of SE PA Bala-Cynwyd Pennsylvania
United States Urology Assoc Medical Group Burbank California
United States Men's Health Boston Chestnut Hill Massachusetts
United States Uropartners, LLC Chicago Illinois
United States Tristate Urologic Services dba TUG Research Cincinnati Ohio
United States Urology Clinics of North Texas, PA Dallas Texas
United States The Urology Center of Colorado Denver Colorado
United States Chesapeake Urology Research Associates Glen Burnie Maryland
United States Bruce R. Gilbert, MD, PhD, PC Great Neck New York
United States Center for Male Reproductive Medicine Hackensack New Jersey
United States Metropolitan Urology P.S.C Jefferson Indiana
United States South Orange County Med Research Center Laguna Hills California
United States Premier Urology Assoc LLC dba AdvanceMed Research Lawrenceville New Jersey
United States Idaho Urologic Institute Meridian Idaho
United States Manhattan Medical Research Practice PLLC New York New York
United States Florida Urology Associates Orlando Florida
United States Kansas City Urology Care, PA Overland Park Kansas
United States Michael A. Werner, MD PC Purchase New York
United States Associated Urologists of North Carolina Raleigh North Carolina
United States Virginia Urology Richmond Virginia
United States Jean Brown Research Salt Lake City Utah
United States San Diego Sexual Medicine San Diego California
United States Chesapeake Urology Research Associates Towson Maryland
United States Urology of Virginia, PLLC Virginia Beach Virginia
United States Georgis Patsias, M.D., PA Wellington Florida
United States Dupage Medical Group Winfield Illinois

Sponsors (1)

Lead Sponsor Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other To assess the long-term immunogenicity profile of AA4500 in adult men with Peyronies disease 5 years post treatment
Primary To assess the long-term safety of AA4500 in adult men with Peyronies disease 5 years post treatment
Secondary To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500 5 years post treatment
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