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

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

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

Study Overview

• Status: Completed
• Conditions: Peyronie's Disease
• Intervention / Treatment: Drug: Subjects Previously Treated with AA4500

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.

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
      • Alaska Clinical Research Center, LLC
  • California
    • Burbank, California, United States, 91505
      • Urology Assoc Medical Group
    • Laguna Hills, California, United States, 92653
      • South Orange County Med Research Center
    • San Diego, California, United States, 92120
      • San Diego Sexual Medicine
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Orlando, Florida, United States, 32803
      • Florida Urology Associates
    • Wellington, Florida, United States, 33449
      • Georgis Patsias, M.D., PA
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Idaho Urologic Institute
  • Illinois
    • Chicago, Illinois, United States, 60612
      • UroPartners, LLC
    • Winfield, Illinois, United States, 60190
      • DuPage Medical Group
  • Indiana
    • Avon, Indiana, United States, 46123
      • Urology of Indiana LLC
    • Jefferson, Indiana, United States, 47130
      • Metropolitan Urology P.S.C
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Urology Care, PA
  • Maryland
    • Glen Burnie, Maryland, United States, 21061
      • Chesapeake Urology Research Associates
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Men's Health Boston
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Center for Male Reproductive Medicine
    • Lawrenceville, New Jersey, United States, 08648
      • Premier Urology Assoc LLC dba AdvanceMed Research
  • New York
    • Albany, New York, United States, 12208
      • Community Care Physicians, PC
    • Great Neck, New York, United States, 11021
      • Bruce R. Gilbert, MD, PhD, PC
    • New York, New York, United States, 10016
      • Manhattan Medical Research Practice PLLC
    • Purchase, New York, United States, 10577
      • Michael A. Werner, MD PC
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Associated Urologists of North Carolina
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • TriState Urologic Services DBA TUG Research
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Urologic Consultants of SE PA
  • Texas
    • Dallas, Texas, United States, 75231
      • Urology Clinics Of North Texas, Pa
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia Urology
    • Virginia Beach, Virginia, United States, 23462
      • Urology Of Virginia, Pllc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Up to 750 subjects who received 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).

Description

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:

   None

   -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No Treatment; 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.	Drug: Subjects Previously Treated with AA4500; no treatment to be administered - observational only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the long-term safety of AA4500 in adult men with Peyronies disease	5 years post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
To characterize curvature deformity over time in adult men with Peyronies disease who were treated with AA4500	5 years post treatment

Other Outcome Measures

Outcome Measure	Time Frame
To assess the long-term immunogenicity profile of AA4500 in adult men with Peyronies disease	5 years post treatment

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): April 9, 2018
• Study Completion (Actual): April 9, 2018

Study Registration Dates

• First Submitted: November 20, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: curvature; bend
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Penile Diseases; Penile Induration
• Other Study ID Numbers: AUX-CC-810