Peyronie's Disease Clinical Trial
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
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 |
Verified date | June 2018 |
Source | Endo Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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: |
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 |
Lead Sponsor | Collaborator |
---|---|
Endo Pharmaceuticals |
United States,
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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