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History of Changes for Study: NCT01221597
Study of AA4500 in the Treatment of Peyronie's Disease
Latest version (submitted September 7, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 14, 2010 None (earliest Version on record)
2 October 25, 2010 Contacts/Locations and Study Status
3 November 5, 2010 Study Status and Contacts/Locations
4 November 9, 2010 Contacts/Locations and Study Status
5 November 16, 2010 Contacts/Locations and Study Status
6 December 6, 2010 Study Status and Contacts/Locations
7 December 27, 2010 Contacts/Locations and Study Status
8 January 17, 2011 Study Status and Contacts/Locations
9 February 2, 2011 Contacts/Locations and Study Status
10 March 14, 2011 Recruitment Status, Contacts/Locations and Study Status
11 September 25, 2012 Recruitment Status, Study Status, Sponsor/Collaborators and Study Design
12 March 24, 2015 Study Status, Outcome Measures, Arms and Interventions, Results, Eligibility, Study Description and Study Identification
13 July 28, 2016 More Information and Study Status
14 September 7, 2016 More Information and Study Status
15 September 7, 2017 Study Status and Outcome Measures
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Study NCT01221597
Submitted Date:  October 14, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: AUX-CC-803
Brief Title: Study of AA4500 in the Treatment of Peyronie's Disease
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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2010
Overall Status: Recruiting
Study Start: September 2010
Primary Completion: March 2012 [Anticipated]
Study Completion: March 2012 [Anticipated]
First Submitted: October 8, 2010
First Submitted that
Met QC Criteria:
October 14, 2010
First Posted: October 15, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 14, 2010
Last Update Posted: October 15, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Endo Pharmaceuticals
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

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.

Detailed Description:
Open or close this module Conditions
Conditions: Peyronie's Disease
Keywords: Peyronie's Disease
penile plaque
penile curvature
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
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 Names:
  • 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 Names:
  • XIAFLEX
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from baseline in the Peyronie's disease bother domain of the Peyronie's Disease Questionnaire (PDQ)
[ Time Frame: Week 52 ]

2. Percent improvement from baseline in penile curvature
[ Time Frame: Week 52 ]

Secondary Outcome Measures:
1. Change from baseline in the severity of Peyronie's disease physical symptoms
[ Time Frame: Week 52 ]

2. 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 ]

3. A responder analysis based on subject global assessment
[ Time Frame: Week 52 ]

4. Change in the overall satisfaction domain of the International Index of Erectile Function (IIEF)
[ Time Frame: Week 52 ]

5. Change in penile plaque consistency
[ Time Frame: Week 52 ]

6. Change in penile length
[ Time Frame: Week 52 ]

7. Change from baseline in the severity of Peyronie's disease psychological symptoms
[ Time Frame: Week 52 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
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

    -

Open or close this module Contacts/Locations
Central Contact Person: Karen Raudibaugh (US)
Telephone: 484 321 5900 Ext. 2123
Email: kraudibaugh@auxilium.com
Central Contact Backup: Nigel Jones (Australia)
Telephone: (44) 1443 421707
Email: njones@auxilium.com
Study Officials: Gregory J. Kaufman, MD
Study Director
Auxilium Pharmaceuticals, Inc.
Locations: United States, Alabama
Urology Centers of Alabama, PC
[Recruiting]
Homewood, Alabama, United States, 35209
Contact:Contact: Cynthia Nasiogik 205-445-0124 cnasiogik@urologyal.com
Contact:Principal Investigator: Brian Christine, MD
United States, Arizona
HOPE Research Institute, LLC
[Not yet recruiting]
Phoenix, Arizona, United States, 85050
Contact:Contact: Bobby Wallace 602-288-4673 bobby.wallace@hriaz.com
Contact:Principal Investigator: Roscoe Nelson, MD
United States, California
Urology Associates Medical Group
[Recruiting]
Burbank, California, United States, 91505
Contact:Contact: Josh Mulnick 818-843-1702 jmulnick@gmail.com
Contact:Principal Investigator: Martin Gelbard, MD
California Professional Research
[Recruiting]
Newport Beach, California, United States, 92660
Contact:Contact: Karen McKerrn 949-644-7214 staff@research.occoxmail.com
Contact:Principal Investigator: Stephen Auerbach, MD
San Diego Sexual Medicine
[Recruiting]
San Diego, California, United States, 92120
Contact:Contact: Sue Goldstein 619-265-8865 suewgoldstein@gmail.com
Contact:Principal Investigator: Irwin Goldstein, MD
United States, Connecticut
Grove Hill Clinical Research, Grove Hill Medical Center
[Recruiting]
New Britain, Connecticut, United States, 06052
Contact:Contact: Amber Albert 860-801-6543 aalbert@grovehill.com
Contact:Principal Investigator: Rafael Wurzel, MD
The Urology Center, PC
[Recruiting]
New Haven, Connecticut, United States, 06511
Contact:Contact: Joanne Wilhelmy 203-789-2222 Ext. 119 office@urologycenter.com
Contact:Principal Investigator: Stanton Honig, MD
United States, Florida
DCT-Celebration, LLC dba Discovery Clinical Trials
[Recruiting]
Celebration, Florida, United States, 34747
Contact:Contact: Cathy Swarner 866-921-5813 rrl2@discoverytrials.com
Contact:Principal Investigator: Richard Lotenfoe, MD
Palm Beach Urology Associates
[Recruiting]
Wellington, Florida, United States, 33414
Contact:Contact: Carmen Franqui 561-753-3175 cfranqui@palmbeachurology.com
Contact:Principal Investigator: Georgis Patsias, MD
United States, Georgia
Southeastern Medical Research Institute
[Recruiting]
Columbus, Georgia, United States, 31904
Contact:Contact: Veta Robinson 706-243-3673 research@harperurology.com
Contact:Principal Investigator: Sean Castellucci, DO
United States, Illinois
DuPage Medical Group
[Recruiting]
Downers Grove, Illinois, United States, 60515
Contact:Contact: Rowie Tran 630-348-3085 Rowie.Tran@dupagemd.com
Contact:Principal Investigator: Craig Smith, MD
United States, Indiana
Urology of Indiana LLC
[Not yet recruiting]
Avon, Indiana, United States, 46123
Contact:Contact: Kimberly Trowbridge 317-893-1511 ktrowbridge@urologyin.com
Contact:Principal Investigator: Ronald Suh, MD
United States, Maryland
Chesapeake Urology Research Associates
[Not yet recruiting]
Baltimore, Maryland, United States, 21204
Contact:Contact: Valerie Nevins 443-471-5740 vnevins@cua.md
Contact:Principal Investigator: Ronald Tutrone, MD
Johns Hopkins Hospital
[Not yet recruiting]
Baltimore, Maryland, United States, 21287
Contact:Contact: Irene Truehart 443-287-1011 itruehe1@jhmi.edu
Contact:Principal Investigator: Arthur Burnett, MD
United States, Massachusetts
Mens Health Boston
[Not yet recruiting]
Brookline, Massachusetts, United States, 02445
Contact:Contact: Randy Eaton 617-277-5444 reaton65@gmail.com
Contact:Principal Investigator: Abraham Morgentaler, MD
United States, Minnesota
Mayo Clinic at Rochester, Dept. of Urology
[Not yet recruiting]
Rochester, Minnesota, United States, 55905
Contact:Contact: Jane Smith 507-266-8788 smith.jane2@mayo.edu
Contact:Principal Investigator: Ajay Nehra, MD
United States, New Jersey
Center for Reproductive Medicine
[Not yet recruiting]
Hackensack, New Jersey, United States, 07601
Contact:Contact: Karen Long 862-202-6835 klong@humed.com
Contact:Principal Investigator: Hossein Sadeghi-Nejad, MD
United States, New York
Division of Urology at Maimonides Medical Center
[Not yet recruiting]
Brooklyn, New York, United States, 11235
Contact:Contact: Kimberly Prabhu 718-283-8596 kprabhu@maimonidesmed.org
Contact:Principal Investigator: Ridwan Shabsigh, MD
Memorial Sloan Kettering Cancer Center
[Not yet recruiting]
New York, New York, United States, 10065
Contact:Contact: Mary Rose Tse 646-227-2329 tsem@mskcc.org
Contact:Principal Investigator: John Mulhall, MD
United States, North Carolina
Alliance Urology Specialists, PA
[Recruiting]
Greensboro, North Carolina, United States, 27403
Contact:Contact: Patricia Edwards 336-274-1114 Ext. 5322 pedwards@allianceurology.com
Contact:Principal Investigator: Sigmund Tannebaum, MD
Wake Urological Associates
[Recruiting]
Raleigh, North Carolina, United States, 27607
Contact:Contact: Jan Vickerson 919-782-1255 jvickerson@gmail.com
Contact:Principal Investigator: Richard Kane, MD
United States, Ohio
Tristate Urologic Services PSC Inc. dba TUG Research
[Recruiting]
Cincinnati, Ohio, United States, 45212
Contact:Contact: William Corbett 513-366-3412 wcorbett@theurologygroup.net
Contact:Principal Investigator: Bernard Hertzman, MD
United States, Pennsylvania
Urology Health Specialists,LLC
[Recruiting]
Bryn Mawr, Pennsylvania, United States, 19010
Contact:Contact: Sharon Oliver 610-525-2515 sharonoliver3@gmail.com
Contact:Principal Investigator: Guy Bernstein, MD
Urological Associates of Lancaster
[Not yet recruiting]
Lancaster, Pennsylvania, United States, 17604
Contact:Contact: Dorie Rodriguez 717-431-2285 ualresearch@yahoo.com
Contact:Principal Investigator: Paul Sieber, MD
United States, Tennessee
Alpha Clinical Research, LLC
[Not yet recruiting]
Clarksville, Tennessee, United States, 37043
Contact:Contact: Kathy Maddox 931-920-2525 kmaddox@alphaclinicalresearch.com
Contact:Principal Investigator: Timothy Duffin, MD
United States, Texas
Urology Associates of North Texas
[Not yet recruiting]
Arlington, Texas, United States, 76017
Contact:Contact: Brenda Vasquez 817-465-8715 Ext. 108 bvasquez@uant.com
Contact:Principal Investigator: Gary Price, MD
Baylor College of Medicine, Department of Urology
[Not yet recruiting]
Houston, Texas, United States, 77030
Contact:Contact: Sharon Harrison 713-798-2240 sharons@bcm.edu
Contact:Principal Investigator: Larry Lipshultz, MD
United States, Utah
Salt Lake Research, PLLC
[Recruiting]
Salt Lake City, Utah, United States, 84107
Contact:Contact: Jennifer Davis 801-288-9778 jdavis@saltlakeresearch.com
Contact:Principal Investigator: Stephen F. Richardson, MD
United States, Virginia
Urology of Virginia - Sentara Medical Group
[Recruiting]
Norfolk, Virginia, United States, 23502
Contact:Contact: Leigh Ann Brand 757-457-5169 laallen@sentara.com
Contact:Principal Investigator: Gerald Jordan, MD
United States, Wisconsin
Medical College of Wisconsin, Department of Urology
[Not yet recruiting]
Milwaukee, Wisconsin, United States, 53226
Contact:Contact: Maria Pigsley 414-805-0791 mpigsley@mcw.edu
Contact:Principal Investigator: Margarita R. Kressin, MD
Australia, New South Wales
Australian Centre for Sexual Health
[Recruiting]
St. Leonards, New South Wales, Australia, NSW 2065
Contact:Contact: Olivia McMahon 61 2 94373906 omcmahon@acsh.com.au
Contact:Principal Investigator: Chris McMahon
Western Urology
[Not yet recruiting]
Westmead, New South Wales, Australia, NSW 2145
Contact:Contact: Marla Luther 02 9633 2088 marla@westernurology.net.au
Contact:Principal Investigator: Andrew Brooks
Australia, Queensland
AusTrials
[Recruiting]
Kipparing, Queensland, Australia, QLD 4019
Contact:Contact: Sharon Horne 61 7 3889 5019 shorne@acro.net.au
Contact:Principal Investigator: Jamie Reynolds
Australia, South Australia
Repatriation General Hospital
[Recruiting]
Daws Park, South Australia, Australia, SA 5041
Contact:Contact: Louise Taylor 08 8275 1020 louise.taylor@health.sa.gov.au
Contact:Principal Investigator: Michael Chong
Australia, Victoria
Australian Urology Associates Pty Ltd
[Not yet recruiting]
Malvern, Victoria, Australia, VIC 3144
Contact:Contact: Kay Talbot 61 3 8506 3600 kayt@aua.com.au
Contact:Principal Investigator: Ross Snow
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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