The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00755222
First received: September 16, 2008
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

This study evaluated the safety and effectiveness of AA4500 in improving the impact of Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's disease


Condition Intervention Phase
Peyronie's Disease
Biological: AA4500
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Two Times a Week for Up to Three Treatment Cycles (2 x 3) in Subjects With Peyronie's Disease

Further study details as provided by Auxilium Pharmaceuticals:

Primary Outcome Measures:
  • Change From Baseline in Penile Curvature [ Time Frame: Baseline and Week 36 or last observation carried forward (LOCF) ] [ Designated as safety issue: No ]
    Negative change reflects improvement in penile curvature

  • Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother [ Time Frame: Baseline to Week 36 or LOCF ] [ Designated as safety issue: No ]

    Peyronie's disease Symptom Bother Scale: 0-20 lower numbers reflect 'less symptom bother'; higher numbers reflect 'more symptom bother'

    Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the symptom bother scale.


  • Change From Baseline in PDQ Intercourse Contraint [ Time Frame: Baseline to Week 36 or LOCF ] [ Designated as safety issue: No ]

    Peyronie's disease intercourse contraint Scale: 0-12 lower numbers reflect 'less intercourse contraint'; higher numbers reflect 'more intercourse constraint'

    Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse constraint scale.


  • Change From Baseline in PDQ Intercourse Discomfort [ Time Frame: Baseline to Week 36 or LOCF ] [ Designated as safety issue: No ]

    Peyronie's disease intercourse discomfort Scale: 0-15 lower numbers reflect 'less intercourse discomfort'; higher numbers reflect 'more intercourse discomfort'

    Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse discomfort scale.


  • Change From Baseline in PDQ Penile Pain [ Time Frame: Baseline to Week 36 or LOCF ] [ Designated as safety issue: No ]
    Peyronie's disease penile pain Scale: 0-40 lower numbers reflect 'less penile pain'; higher numbers reflect 'more penile pain' Change from baseline=Week 36 minus baseline. Negative change reflects improvement in the penile pain scale.


Enrollment: 147
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AA4500
Clostridial collagenase for injection
Biological: AA4500
2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series was separated by 6 weeks.
Other Name: Clostridial collagenase for injection (AA4500)
Placebo Comparator: Placebo Biological: Placebo
2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series is separated by 6 weeks.

Detailed Description:

A Phase 2b randomized, double-blind, placebo-controlled study of AA4500 in the treatment of subjects with Peyronie's disease.

During the screening period, subjects had a physical examination including body weight and height, vital sign measurements, a 12-lead electrocardiogram (ECG), and clinical laboratory testing. Medical history, prior and concomitant medications, and demographic data were recorded.

  Eligibility

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

Inclusion Criteria:

  • Heterosexual male ≥ 18 years of age
  • In a stable relationship with a partner/spouse for at least 3 months before screening
  • Have a diagnosis of Peyronie's disease for at least 6 months before first dose of study drug
  • Have a penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane
  • Have functional difficulty related to Peyronie's disease (eg, difficulty with intromission or erectile dysfunction)
  • Be judged to be in good health based upon the results of medical history, physical examination and laboratory profile
  • Voluntarily sign an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must have also signed an authorization form to allow disclosure of his protected health information. The protected health information authorization form and informed consent form may have been an integrated form or may have been separate forms, depending on the institution
  • Be able to complete and understand the various rating instruments

Exclusion Criteria:

  • Have had an average of three successive blood pressure readings ≥ 160/100 mmHg during screening or the Day 1 assessments
  • Severe pain during penile palpation
  • Any of the following conditions:

    • Chordee in the presence or absence of hypospadias
    • Thrombosis of the dorsal penile artery
    • 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 sexually transmitted disease
    • Known Hepatitis B or C
    • Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
  • Previously undergone surgery for Peyronie's disease
  • Penile curvature of less than 30° or greater than 90°
  • Failed to have a rigid erection after pharmacological stimulation with a vasoactive injection of Prostaglandin E1 10 to 20 µg, which, in the opinion of the investigator, was sufficient to accurately measure the subject's penile deformity
  • Had a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray, or penile ultrasound. Non-contiguous stippling of calcium was acceptable for inclusion
  • Had an isolated hourglass deformity of the penis without curvature
  • Had the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would have interfered with the injection of AA4500 into the plaque
  • 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
  • Received alternative medical therapies for Peyronie's disease administered by the oral (including, but not limited to, vitamin E (>500IU), 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 4 weeks before the first dose of study drug or plans to use any of these medical therapies at any time during the study
  • 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
  • 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
  • Significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
  • Recent history of stroke, bleeding, or other medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study
  • Unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
  • Received an investigational drug or treatment within 30 days before the first dose of study drug
  • Allergy to collagenase or any other excipient of AA4500
  • Allergy to any concomitant medication required as per the protocol
  • 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
  • Received doxycycline or a tetracycline derivative during the 7 days before each dose of study drug or plans to use these drugs within 2 days after the injection of study drug
  • Received any collagenase treatments within 30 days of the first dose of study drug
  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: NCT00755222

Locations
United States, California
Urology Associates Medical Group
Burbank, California, United States, 91505
United States, Connecticut
Urology Specialists Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, United States, 06762
The Urology Center, PC
New Haven, Connecticut, United States, 06511
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
United States, Illinois
Urology Specialists, SC
Chicago, Illinois, United States, 60612
United States, Indiana
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States, 46825
Metropolitan Urology, PSC
Jeffersonville, Indiana, United States, 47130
United States, New York
Maimonides Medical Center Divison of Urology
Brooklyn, New York, United States, 11219
University Urology Associates
New York, New York, United States, 10016
United States, Ohio
Tristate Urologic Services
Cincinnati, Ohio, United States, 45212
United States, Texas
Baylor College of Medicine, Scott Department of Urology
Houston, Texas, United States, 77030
United States, Virginia
Urology of Virginia (a division of Sentara Medical Group)
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Auxilium Pharmaceuticals
Investigators
Study Director: Gregory Kaufman, MD Auxilium Pharmaceuticals
  More Information

No publications provided

Responsible Party: Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00755222     History of Changes
Other Study ID Numbers: AUX-CC-801
Study First Received: September 16, 2008
Results First Received: January 18, 2011
Last Updated: January 24, 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
Connective Tissue Diseases
Genital Diseases, Male
Penile Diseases

ClinicalTrials.gov processed this record on October 23, 2014