A Study of AA4500 in Men With Peyronie's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01243411
First received: November 17, 2010
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Peyronie's Disease
Biological: AA4500
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for up to Four Treatment Cycles (2 x 4) in Men With Peyronie's Disease

Resource links provided by NLM:


Further study details as provided by Auxilium Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in the Peyronie's disease bother domain of the Peyronie's Disease Questionnaire (PDQ) [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Percent improvement from baseline in penile curvature [ Time Frame: Week 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the severity of Peyronie's disease physical symptoms [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Change in the penile pain domain of the PDQ in subjects with penile pain score of at least 4 at baseline [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • A responder analysis based on subject global assessment [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Change in the overall satisfaction domain of the IIEF [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Change in penile plaque consistency [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Change in penile length [ Time Frame: Week 36 ] [ Designated as safety issue: No ]
  • Change from baseline in the severity of Peyronie's disease psychological symptoms [ Time Frame: Week 36 ] [ Designated as safety issue: No ]

Enrollment: 348
Study Start Date: November 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AA4500
collagenase clostridium histolyticum
Biological: AA4500
2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)
Other Name: XIAFLEX

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  1. Be a male and be ≥ 18 years of age
  2. 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
  3. 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
  4. 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
  5. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile
  6. 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
  7. 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.

    -

Exclusion Criteria:

A subject will be excluded from study participation if he:

  1. Has a penile curvature of less than 30° or greater than 90° at the screening visit
  2. 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)
  3. Has previously undergone surgery for Peyronie's disease
  4. 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
  5. 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
  6. Has an isolated hourglass deformity of the penis
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  12. 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
  13. Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
  14. Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant
  15. Has uncontrolled hypertension, as determined by the investigator
  16. 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
  17. Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
  18. Has received an investigational drug or treatment within 30 days before the first dose of study drug, except for subjects who receive one treatment cycle of AA4500 in Study AUX-CC-805
  19. Has a known systemic allergy to collagenase or any other excipient of AA4500
  20. Has a known allergy to any concomitant medication required as per the protocol
  21. Has received anticoagulant medication (except for ≤ 165 mg aspirin daily or ≤ 800 mg of over-the-counter NSAIDS daily) during the 7 days before each dose of study drug
  22. Has received any collagenase treatments within 30 days of the first dose of study drug, except for subjects who receive one treatment cycle of AA4500 in Study AUX-CC-805
  23. Has, at any time, received AA4500 for the treatment of Peyronie's disease, except for subjects who receive one treatment cycle of AA4500 in Study AUX-CC-805
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243411

  Hide Study Locations
Locations
United States, California
Urology Associates Medical Group
Burbank, California, United States, 91505
United States, Connecticut
Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, United States, 06762
The Urology Center, P.C.
New Haven, Connecticut, United States, 06511
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
United States, Illinois
Urology Specialists, S.C.
Chicago, Illinois, United States, 60612
United States, Indiana
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States, 46825
Metropolitan Urology, P.S.C.
Jeffersonville, Indiana, United States, 47130
United States, New York
Maimonides Medical Center, Division of Urology
Brooklyn, New York, United States, 11219
University Urology Associates
New York, New York, United States, 10016
United States, Ohio
Tristate Urologic Services PSC, Inc./ dba TUG Research
Cincinnati, Ohio, United States, 45212
United States, Pennsylvania
Urologic Consultants of SE PA
Bala Cynwyd, Pennsylvania, United States, 19004
United States, Virginia
Urology of Virginia-Sentara Medical Group
Norfolk, Virginia, United States, 23502
Virginia Urology
Richmond, Virginia, United States, 23235
Denmark
Aarhus Universitiy Hospital, Aalborg Sygehus
Aalborg, Denmark, DK-9100
Frederiksberg Hospital
Frederiksberg, Denmark, DK-2000
Frederikssunds Hospital
Frederikssund, Denmark, DK-3600
Klinik for seksuelle dysfunktioner
Gentofte, Denmark, DK-2820
France
Centre Hospitalier Edouar Herriot
Lyon, France, F-69 437
Hopital Henri Gabrielle
Saint Genis Laval, France, F-69230
Germany
Universitatsklinikum Freiburg, Abteilung Urologie
Freiburg, Germany, DE-79106
Private Practice of Urology/Andrology
Hamburg, Germany, DE-20354
Uro-Onkologische Praxis Dr. von Keitz
Marburg, Germany, DE-35039
Urologische Gemeinschaftspraxis Reutlingen
Reutlingen, Germany, DE-72764
Universitatsklinikum Tubingen
Tubingen, Germany, DE-72096
Italy
University of Naples "Federico II"
Naples, Italy, I-80131
Universitiy Tor Vergatat of Rome
Rome, Italy, I-00133
New Zealand
Waitemata Urology Research North Shore Hospital
Takapuna, Auckland, New Zealand, 0622
Tauranga Urology Research Ltd.
Tauranga, Bay of Plenty, New Zealand, 3140
CURT Medical Trials Trust Board Inc.
Christchurch, Canterbury, New Zealand, 8014
Primorus Clinical Trials Ltd.
Christchurch, Canterbury, New Zealand, 8011
Cardinal Points Research Ltd.
Whangarei, Northland, New Zealand, 0112
Wellington Urology Associates
Wellington South, Wellington, New Zealand, 6021
Spain
Hospital Clinic de Barcelona
Barcelona, Spain, ES-08036
Hospital La Zarzuela
Madrid, Spain, ES-28043
Sweden
Specialistmottagningen i urologi
Goteborg, Sweden, SE-405 45
Carlshamns Specialistklinik
Karlshamn, Sweden, SE-374 35
Akademiska Sjukhuse
Uppsala, Sweden, SE-751 85
United Kingdom
St. Peter's Andrology Centre
London, United Kingdom, W1G 6BJ
Sunderland Royal Hospital
Sunderland, United Kingdom, SR4 &TP
Sponsors and Collaborators
Auxilium Pharmaceuticals
Investigators
Study Director: Gregory J. Kaufman, MD Auxilium Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01243411     History of Changes
Other Study ID Numbers: AUX-CC-802
Study First Received: November 17, 2010
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
New Zealand: Medsafe
Germany: BfArM
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency

Keywords provided by Auxilium Pharmaceuticals:
Peyronie's Disease, penile plaque, penile curvature

Additional relevant MeSH terms:
Penile Induration
Penile Diseases
Genital Diseases, Male
Connective Tissue Diseases

ClinicalTrials.gov processed this record on September 11, 2014