A Study of AA4500 in Men With Peyronie's Disease

Completed · Phase 3

Conditions studied: Peyronie's Disease

In brief

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.

Key facts

Study ID: NCT01243411
Run by: Endo USA Inc., a Keenova Therapeutics Company
People needed: 348
Starts: 2010-11-01
Expected to finish: 2012-08-01
Last updated by the study team: 2017-10-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

No subject should be enrolled until all eligibility criteria have been satisfied. Subjects who receive placebo in a previous Auxilium-sponsored study may enroll in this study provided they continue to meet the eligibility requirements. To qualify for the study a subject must:
Be a male and be ≥ 18 years of age
Be in a stable relationship with a female partner/spouse for at least 3 months before screening and be willing to have vaginal intercourse with that partner/spouse
Have symptom(s) of Peyronie's disease for at least 12 months before the first dose of study drug and have evidence of stable disease as determined by the investigator
Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the single plane of maximal curvature for evaluation during the study
Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile
Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution
Be able to read, complete and understand the various rating instruments in English or the appropriate local language for the country in which the study is being performed.

You may not qualify if…

A subject will be excluded from study participation if he:
Has a penile curvature of less than 30° or greater than 90° at the screening visit
Has any of the following conditions:
Chordee in the presence or absence of hypospadias
Thrombosis of the dorsal penile artery and/or vein
Infiltration by a benign or malignant mass resulting in penile curvature
Infiltration by an infectious agent, such as lymphogranuloma venereum
Ventral curvature from any cause
Presence of an active sexually transmitted disease
Known active hepatitis B or C
Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
Has previously undergone surgery for Peyronie's disease
Fails to have an erection which in the opinion of the investigator is sufficient to accurately measure the subject's penile deformity after administration of prostaglandin E1 or trimix
Has a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray or penile ultrasound that would prevent proper injection of study medication (penile ultrasound only in EU countries). Non-contiguous stippling of calcium is acceptable for inclusion provided the calcium deposit does not interfere with the injection of AA4500 into the plaque
Has an isolated hourglass deformity of the penis
Has the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would interfere with the injection of AA4500 into the plaque
Has previously received alternative medical therapies for Peyronie's disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study
Has received alternative medical therapies for Peyronie's disease administered by the oral (including, but not limited to, vitamin E [> 500 U], potassium aminobenzoate [Potaba], tamoxifen, colchicine, pentoxifylline, over-the-counter erectile dysfunction medications, or steroidal anti-inflammatory drugs) or topical routes (including, but not limited to, verapamil applied as a cream) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study
Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie's disease within the 6-month period before screening or plans to have ESWT at any time during the study
Has used any mechanical type device for correction of Peyronie's disease within the 2-week period before screening or plans to use any these devices at any time during the study
Has used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study
Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant
Has uncontrolled hypertension, as determined by the investigator
Has a known recent history of stroke, bleeding, or other significant medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study

Where it is running

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
Aarhus Universitiy Hospital, Aalborg Sygehus — Aalborg, Denmark
Frederiksberg Hospital — Frederiksberg, Denmark
Frederikssunds Hospital — Frederikssund, Denmark
Klinik for seksuelle dysfunktioner — Gentofte Municipality, Denmark
Centre Hospitalier Edouar Herriot — Lyon, France
Hopital Henri Gabrielle — Saint-Genis-Laval, France
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
University of Naples "Federico II" — Naples, Italy

Full record on ClinicalTrials.gov

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