Trial record 1 of 1 for:    NCT01221597
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Study of AA4500 in the Treatment of Peyronie's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01221597
First received: October 8, 2010
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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 >60º) 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 further treatment is not clinically indicated, 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 168 (± 7 days), 231 (± 7 days), 294 (± 7 days), 364 (± 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-blind, Randomized, Placebo-controlled 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 52 ] [ Designated as safety issue: No ]
  • Percent improvement from baseline in penile curvature [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the severity of Peyronie's disease physical symptoms [ Time Frame: Week 52 ] [ 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 52 ] [ Designated as safety issue: No ]
  • A responder analysis based on subject global assessment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in the overall satisfaction domain of the International Index of Erectile Function (IIEF) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in penile plaque consistency [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in penile length [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in the severity of Peyronie's disease psychological symptoms [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 418
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: March 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. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
Other Name: XIAFLEX
Placebo Comparator: Placebo Biological: AA4500
2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
Other Name: XIAFLEX

  Eligibility

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

Inclusion Criteria:

  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

Exclusion criteria

  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 (PGE1) 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. 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 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
  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 non-steroidal anti-inflammatory drugs [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
  23. Has, at any time, received AA4500 for the treatment of Peyronie's disease

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  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: NCT01221597

  Show 34 Study Locations
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: NCT01221597     History of Changes
Other Study ID Numbers: AUX-CC-803
Study First Received: October 8, 2010
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration

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 August 01, 2014