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A Study of AA4500 in Men With Peyronie's Disease

Primary Purpose

Peyronie's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AA4500
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peyronie's Disease focused on measuring Peyronie's Disease, penile plaque, penile curvature

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urology Associates Medical Group
  • Connecticut Clinical Research Center, LLC
  • The Urology Center, P.C.
  • South Florida Medical Research
  • Urology Specialists, S.C.
  • Northeast Indiana Research, LLC
  • Metropolitan Urology, P.S.C.
  • Maimonides Medical Center, Division of Urology
  • University Urology Associates
  • Tristate Urologic Services PSC, Inc./ dba TUG Research
  • Urologic Consultants of SE PA
  • Urology of Virginia-Sentara Medical Group
  • Virginia Urology
  • Aarhus Universitiy Hospital, Aalborg Sygehus
  • Frederiksberg Hospital
  • Frederikssunds Hospital
  • Klinik for seksuelle dysfunktioner
  • Centre Hospitalier Edouar Herriot
  • Hopital Henri Gabrielle
  • Universitatsklinikum Freiburg, Abteilung Urologie
  • Private Practice of Urology/Andrology
  • Uro-Onkologische Praxis Dr. von Keitz
  • Urologische Gemeinschaftspraxis Reutlingen
  • Universitatsklinikum Tubingen
  • University of Naples "Federico II"
  • Universitiy Tor Vergatat of Rome
  • Waitemata Urology Research North Shore Hospital
  • Tauranga Urology Research Ltd.
  • Primorus Clinical Trials Ltd.
  • CURT Medical Trials Trust Board Inc.
  • Cardinal Points Research Ltd.
  • Wellington Urology Associates
  • Hospital Clinic de Barcelona
  • Hospital La Zarzuela
  • Specialistmottagningen i urologi
  • Carlshamns Specialistklinik
  • Akademiska Sjukhuse
  • St. Peter's Andrology Centre
  • Sunderland Royal Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AA4500

Arm Description

collagenase clostridium histolyticum

Outcomes

Primary Outcome Measures

Percentage Change From Baseline in Penile Curvature
A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.
Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)
Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.

Secondary Outcome Measures

Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ
Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.
Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4
Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.
A Responder Analysis Based on Subject Overall Global Assessment
Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.
Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)
Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.
Change From Baseline in Penile Plaque Consistency
Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.
A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score
A composite responder is indicated by a percent reduction from baseline in penile curvature greater than or equal to the threshold, and a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening.
Change From Baseline in Penile Length
A negative value represents a reduction in measurement from baseline.

Full Information

First Posted
November 17, 2010
Last Updated
September 7, 2017
Sponsor
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01243411
Brief Title
A Study of AA4500 in Men With Peyronie's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peyronie's Disease
Keywords
Peyronie's Disease, penile plaque, penile curvature

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AA4500
Arm Type
Experimental
Arm Description
collagenase clostridium histolyticum
Intervention Type
Biological
Intervention Name(s)
AA4500
Other Intervention Name(s)
XIAFLEX
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentage Change From Baseline in Penile Curvature
Description
A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.
Time Frame
Baseline and Week 36
Title
Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)
Description
Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.
Time Frame
Baseline and Week 36
Secondary Outcome Measure Information:
Title
Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ
Description
Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.
Time Frame
Baseline and Week 36
Title
Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4
Description
Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.
Time Frame
Baseline and Week 36
Title
A Responder Analysis Based on Subject Overall Global Assessment
Description
Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.
Time Frame
Week 36
Title
Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)
Description
Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.
Time Frame
Baseline and Week 36
Title
Change From Baseline in Penile Plaque Consistency
Description
Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.
Time Frame
Baseline and Week 36
Title
A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score
Description
A composite responder is indicated by a percent reduction from baseline in penile curvature greater than or equal to the threshold, and a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening.
Time Frame
Week 36
Title
Change From Baseline in Penile Length
Description
A negative value represents a reduction in measurement from baseline.
Time Frame
Baseline and Week 36

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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: 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 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 (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 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 the 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 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 Has a known systemic allergy to collagenase or any other excipient of AA4500 Has a known allergy to any concomitant medication required as per the protocol 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory J. Kaufman, MD
Organizational Affiliation
Auxilium Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Urology Associates Medical Group
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Connecticut Clinical Research Center, LLC
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
The Urology Center, P.C.
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Urology Specialists, S.C.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Northeast Indiana Research, LLC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Metropolitan Urology, P.S.C.
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Maimonides Medical Center, Division of Urology
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Tristate Urologic Services PSC, Inc./ dba TUG Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Urologic Consultants of SE PA
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Urology of Virginia-Sentara Medical Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Urology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Aarhus Universitiy Hospital, Aalborg Sygehus
City
Aalborg
ZIP/Postal Code
DK-9100
Country
Denmark
Facility Name
Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
DK-2000
Country
Denmark
Facility Name
Frederikssunds Hospital
City
Frederikssund
ZIP/Postal Code
DK-3600
Country
Denmark
Facility Name
Klinik for seksuelle dysfunktioner
City
Gentofte
ZIP/Postal Code
DK-2820
Country
Denmark
Facility Name
Centre Hospitalier Edouar Herriot
City
Lyon
ZIP/Postal Code
F-69 437
Country
France
Facility Name
Hopital Henri Gabrielle
City
Saint Genis Laval
ZIP/Postal Code
F-69230
Country
France
Facility Name
Universitatsklinikum Freiburg, Abteilung Urologie
City
Freiburg
ZIP/Postal Code
DE-79106
Country
Germany
Facility Name
Private Practice of Urology/Andrology
City
Hamburg
ZIP/Postal Code
DE-20354
Country
Germany
Facility Name
Uro-Onkologische Praxis Dr. von Keitz
City
Marburg
ZIP/Postal Code
DE-35039
Country
Germany
Facility Name
Urologische Gemeinschaftspraxis Reutlingen
City
Reutlingen
ZIP/Postal Code
DE-72764
Country
Germany
Facility Name
Universitatsklinikum Tubingen
City
Tubingen
ZIP/Postal Code
DE-72096
Country
Germany
Facility Name
University of Naples "Federico II"
City
Naples
ZIP/Postal Code
I-80131
Country
Italy
Facility Name
Universitiy Tor Vergatat of Rome
City
Rome
ZIP/Postal Code
I-00133
Country
Italy
Facility Name
Waitemata Urology Research North Shore Hospital
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Tauranga Urology Research Ltd.
City
Tauranga
State/Province
Bay of Plenty
ZIP/Postal Code
3140
Country
New Zealand
Facility Name
Primorus Clinical Trials Ltd.
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
CURT Medical Trials Trust Board Inc.
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8014
Country
New Zealand
Facility Name
Cardinal Points Research Ltd.
City
Whangarei
State/Province
Northland
ZIP/Postal Code
0112
Country
New Zealand
Facility Name
Wellington Urology Associates
City
Wellington South
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
ES-08036
Country
Spain
Facility Name
Hospital La Zarzuela
City
Madrid
ZIP/Postal Code
ES-28043
Country
Spain
Facility Name
Specialistmottagningen i urologi
City
Goteborg
ZIP/Postal Code
SE-405 45
Country
Sweden
Facility Name
Carlshamns Specialistklinik
City
Karlshamn
ZIP/Postal Code
SE-374 35
Country
Sweden
Facility Name
Akademiska Sjukhuse
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
Facility Name
St. Peter's Andrology Centre
City
London
ZIP/Postal Code
W1G 6BJ
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
ZIP/Postal Code
SR4 &TP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25388099
Citation
Levine LA, Cuzin B, Mark S, Gelbard MK, Jones NA, Liu G, Kaufman GJ, Tursi JP, Ralph DJ. Clinical safety and effectiveness of collagenase clostridium histolyticum injection in patients with Peyronie's disease: a phase 3 open-label study. J Sex Med. 2015 Jan;12(1):248-58. doi: 10.1111/jsm.12731. Epub 2014 Nov 12.
Results Reference
derived

Learn more about this trial

A Study of AA4500 in Men With Peyronie's Disease

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