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Clinical trialNCT01243411CompletedPhase 3Interventional

A Study of AA4500 in Men With Peyronie's Disease

SponsorEndo USA Inc., a Keenova Therapeutics CompanyEnrollment348Peyronie's Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. After up to four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36). After the final injection of each treatment cycle, the investigator will model the plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to \<15° after the first, second, or third cycle of injections or if the investigator determines further treatment is not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles will not be administered. Approximately 300 subjects will be enrolled.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

39 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Denmark
  • Aarhus Universitiy Hospital, Aalborg Sygehus

    Aalborg, Denmark

  • Frederiksberg Hospital

    Frederiksberg, Denmark

  • Frederikssunds Hospital

    Frederikssund, Denmark

  • Klinik for Seksuelle Dysfunktioner

    Gentofte Municipality, Denmark

France
  • Centre Hospitalier Edouar Herriot

    Lyon, France

  • Hopital Henri Gabrielle

    Saint-Genis-Laval, France

Germany
  • Universitatsklinikum Freiburg, Abteilung Urologie

    Freiburg im Breisgau, Germany

  • Private Practice of Urology/andrology

    Hamburg, Germany

  • Uro-Onkologische Praxis Dr. Von Keitz

    Marburg, Germany

  • Urologische Gemeinschaftspraxis Reutlingen

    Reutlingen, Germany

  • Universitatsklinikum Tubingen

    Tübingen, Germany

Italy
  • University of Naples "federico Ii"

    Naples, Italy

  • Universitiy Tor Vergatat of Rome

    Rome, Italy

New Zealand
  • Waitemata Urology Research North Shore Hospital

    Takapuna, Auckland, New Zealand

  • Tauranga Urology Research Ltd.

    Tauranga, Bay of Plenty, New Zealand

  • Curt Medical Trials Trust Board Inc.

    Christchurch, Canterbury, New Zealand

  • Primorus Clinical Trials Ltd.

    Christchurch, Canterbury, New Zealand

  • Cardinal Points Research Ltd.

    Whangarei, Northland, New Zealand

  • Wellington Urology Associates

    Wellington South, Wellington Region, New Zealand

Spain
  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital la Zarzuela

    Madrid, Spain

Sweden
  • Specialistmottagningen I Urologi

    Gothenburg, Sweden

  • Carlshamns Specialistklinik

    Karlshamn, Sweden

  • Akademiska Sjukhuse

    Uppsala, Sweden

United Kingdom
  • St. Peter'S Andrology Centre

    London, United Kingdom

  • Sunderland Royal Hospital

    Sunderland, United Kingdom

United States
  • Urology Associates Medical Group

    Burbank, California, United States

  • Connecticut Clinical Research Center, Llc

    Middlebury, Connecticut, United States

  • the Urology Center, P.C.

    New Haven, Connecticut, United States

  • South Florida Medical Research

    Aventura, Florida, United States

  • Urology Specialists, S.C.

    Chicago, Illinois, United States

  • Northeast Indiana Research, Llc

    Fort Wayne, Indiana, United States

  • Metropolitan Urology, P.S.C.

    Jeffersonville, Indiana, United States

  • Maimonides Medical Center, Division of Urology

    Brooklyn, New York, United States

  • University Urology Associates

    New York, New York, United States

  • Tristate Urologic Services Psc, Inc./ Dba Tug Research

    Cincinnati, Ohio, United States

  • Urologic Consultants of Se Pa

    Bala-Cynwyd, Pennsylvania, United States

  • Urology of Virginia-Sentara Medical Group

    Norfolk, Virginia, United States

  • Virginia Urology

    Richmond, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AA4500
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2010
Primary completion
31 Aug 2012
Completion
31 Aug 2012
Last update posted
5 Oct 2017
Registered enrollment
348
Registry id
NCT01243411
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.