Study of AA4500 in the Treatment of Peyronie's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Peyronie's Disease

In brief

This study is a Phase 3, double-blind, randomized, placebo-controlled study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Approximately 300 (200 AA4500 and 100 placebo) men will be randomized. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. Before dosing, subjects will be stratified by degree of penile curvature (ie, 30º to 60º or 61º to 90º) and then randomized into two treatment groups to receive in a 2:1 ratio either AA4500 0.58 mg or placebo. In this study, qualified subjects may receive up to four treatment cycles; each cycle will be separated by a period of 42 days (± 5 days). During each treatment cycle, subjects will receive two injections of study drug with at least 24 hours but not more than 72 hours between injections. After the final injection of each treatment cycle, the investigator or qualified designee will model the penile plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to \< 15 degrees 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. Following the maximum of four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 169 (± 7 days), 232 (± 7 days), 295 (± 7 days), 365 (± 7 days) (nominal weeks 24, 33, 42 and 52). Subjects randomized to placebo may receive open-label AA4500 treatment after completing this study as part of another protocol.

Key facts

Study ID

NCT01221623

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

418

Starts

2010-10-01

Expected to finish

2012-03-01

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…

• 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

You may not qualify if…

• 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 (PGE1) 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. 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 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
• Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits

Where it is running

• Costal Clinical Research, Inc. — Mobile, Alabama, United States
• Alaska Clinical Research Center, LLC — Anchorage, Alaska, United States
• Connect Clinical Research Center (CCRC) — Phoenix, Arizona, United States
• So. Orange County Medical Research Center — Laguna Hills, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Connecticut Clinical Resarch Center, LLC — Middlebury, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• Winter Park Urology Associates — Orlando, Florida, United States
• Idaho Urologic Institute — Meridian, Idaho, United States
• Northeast Indiana Research, LLC — Fort Wayne, Indiana, United States
• Metropolitan Urology, P.S.C. — Jeffersonville, Indiana, United States
• Kansas City Urology Care, P.A. Research Department — Overland Park, Kansas, United States
• Tulane University Health Sciences Center Dept. of Urology — New Orleans, Louisiana, United States
• Regional Urology L.L.C. — Shreveport, Louisiana, United States
• Chesapeake Urology Research Assoc. — Glen Burnie, Maryland, United States
• Chesapeake Urology Research Assoc., PA — Towson, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Cooper Health System — Camden, New Jersey, United States
• AdvanceMed Research — Lawrenceville, New Jersey, United States
• The Capital Region Medical Research Foundation @ the Urological Institute of Northeastern New York — Albany, New York, United States
• Bruce R. Gilbert, MD, PhD, PC — Great Neck, New York, United States
• University Urology Associates — New York, New York, United States
• Michael A. Werner, MD, PC — Purchase, New York, United States
• Universitiy of North Carolina School of Medicine Div. of Urology — Chapel Hill, North Carolina, United States
• Duke University Medical Center Division of Urologic Surgery — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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