Long-term Safety, Curvature Deformity Characterization, and Immunogenicity Over Time in Subjects Previously Treated With AA4500 for Peyronies Disease
- Conditions
- Peyronie's Disease
- Interventions
- Drug: Subjects Previously Treated with AA4500
- Registration Number
- NCT02298829
- Lead Sponsor
- Endo Pharmaceuticals
- 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 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 & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 184
-
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).
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No Treatment Subjects Previously Treated with AA4500 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.
- Primary Outcome Measures
Name Time Method To assess the long-term safety of AA4500 in adult men with Peyronies disease 5 years post treatment
- Secondary Outcome Measures
Name Time Method To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500 5 years post treatment
Trial Locations
- Locations (29)
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Bruce R. Gilbert, MD, PhD, PC
🇺🇸Great Neck, New York, United States
Uropartners, LLC
🇺🇸Chicago, Illinois, United States
Men's Health Boston
🇺🇸Chestnut Hill, Massachusetts, United States
Metropolitan Urology P.S.C
🇺🇸Jefferson, Indiana, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Urology Assoc Medical Group
🇺🇸Burbank, California, United States
South Orange County Med Research Center
🇺🇸Laguna Hills, California, United States
Georgis Patsias, M.D., PA
🇺🇸Wellington, Florida, United States
Idaho Urologic Institute
🇺🇸Meridian, Idaho, United States
Urology of Indiana LLC
🇺🇸Avon, Indiana, United States
Manhattan Medical Research Practice PLLC
🇺🇸New York, New York, United States
Kansas City Urology Care, PA
🇺🇸Overland Park, Kansas, United States
Michael A. Werner, MD PC
🇺🇸Purchase, New York, United States
Center for Male Reproductive Medicine
🇺🇸Hackensack, New Jersey, United States
Community Care Physicians, PC
🇺🇸Albany, New York, United States
Florida Urology Associates
🇺🇸Orlando, Florida, United States
Alaska Clinical Research Center, LLC
🇺🇸Anchorage, Alaska, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Dupage Medical Group
🇺🇸Winfield, Illinois, United States
Premier Urology Assoc LLC dba AdvanceMed Research
🇺🇸Lawrenceville, New Jersey, United States
San Diego Sexual Medicine
🇺🇸San Diego, California, United States
Chesapeake Urology Research Associates
🇺🇸Towson, Maryland, United States
Tristate Urologic Services dba TUG Research
🇺🇸Cincinnati, Ohio, United States
Urology Clinics of North Texas, PA
🇺🇸Dallas, Texas, United States
Urology of Virginia, PLLC
🇺🇸Virginia Beach, Virginia, United States
Urologic Consultants of SE PA
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Associated Urologists of North Carolina
🇺🇸Raleigh, North Carolina, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States