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

Completed

Conditions studied: Peyronie's Disease

In brief

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

Key facts

Study ID

NCT02298829

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

184

Starts

2014-11-01

Expected to finish

2018-04-09

Last updated by the study team

2018-06-20

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• None

Where it is running

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

Full record on ClinicalTrials.gov

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