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Trial record 98 of 494 for:    penis

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

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ClinicalTrials.gov Identifier: NCT01685437
Recruitment Status : Completed
First Posted : September 14, 2012
Results First Posted : April 7, 2015
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peyronie's Disease
Intervention Biological: AA4500
Enrollment 189
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AA4500
Hide Arm/Group Description

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Period Title: Overall Study
Started 189
Completed 158
Not Completed 31
Reason Not Completed
Withdrawal by Subject             22
Lost to Follow-up             3
Adverse Event             1
Protocol Violation             4
Unable to make visits due to work             1
Arm/Group Title AA4500
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collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Overall Number of Baseline Participants 189
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants
<=18 years
0
   0.0%
Between 18 and 65 years
134
  70.9%
>=65 years
55
  29.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 189 participants
60.2  (7.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants
Female
0
   0.0%
Male
189
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants
Hispanic or Latino
5
   2.6%
Not Hispanic or Latino
184
  97.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   0.5%
Black or African American
1
   0.5%
White
186
  98.4%
More than one race
0
   0.0%
Unknown or Not Reported
1
   0.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 189 participants
United States 162
Australia 27
1.Primary Outcome
Title Percentage Change From Baseline in Penile Curvature
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on modified intent-to-treat (mITT) population.
Arm/Group Title AA4500
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: percentage of curvature change
-36.3  (30.72)
2.Primary Outcome
Title Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (3.34)
3.Secondary Outcome
Title Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.9  (4.76)
4.Secondary Outcome
Title Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.
Arm/Group Title AA4500
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.5  (4.75)
5.Secondary Outcome
Title A Responder Analysis Based on Subject Overall Global Assessment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Overall Number of Participants Analyzed 126
Measure Type: Number
Unit of Measure: participants
Responder Status - No 32
Responder Status - Yes 94
6.Secondary Outcome
Title Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.7  (2.13)
7.Secondary Outcome
Title Change From Baseline in Penile Plaque Consistency
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.4  (0.81)
8.Secondary Outcome
Title A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Composite responder analysis is based on the intent-to-treat (ITT) population.
Arm/Group Title AA4500
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: participants
No 85
Yes 83
Missing 21
9.Secondary Outcome
Title Change From Baseline in Penile Length
Hide Description A negative value represents a reduction in measurement from baseline.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

Overall Number of Participants Analyzed 126
Mean (Standard Deviation)
Unit of Measure: centimeters
0.2  (1.16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AA4500
Hide Arm/Group Description

collagenase clostridium histolyticum

AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles

All-Cause Mortality
AA4500
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AA4500
Affected / at Risk (%) # Events
Total   3/189 (1.59%)    
Gastrointestinal disorders   
Caecitis * 1  1/189 (0.53%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acoustic neuroma * 1  1/189 (0.53%)  1
Renal and urinary disorders   
Calculus ureteric * 1  1/189 (0.53%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AA4500
Affected / at Risk (%) # Events
Total   178/189 (94.18%)    
General disorders   
Injection site haematoma * 1  35/189 (18.52%)  66
Injection site pain * 1  32/189 (16.93%)  50
Injection site haemorrhage * 1  21/189 (11.11%)  56
Injection site swelling * 1  20/189 (10.58%)  27
Injury, poisoning and procedural complications   
Contusion * 1  17/189 (8.99%)  20
Reproductive system and breast disorders   
Penile haematoma * 1  114/189 (60.32%)  271
Penile pain * 1  64/189 (33.86%)  121
Penile swelling * 1  57/189 (30.16%)  99
Penile oedema * 1  46/189 (24.34%)  91
Penile haemorrhage * 1  39/189 (20.63%)  73
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals, Inc.
EMail: clinicalsite.inquiries@endo.com
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01685437     History of Changes
Other Study ID Numbers: AUX-CC-806
First Submitted: September 12, 2012
First Posted: September 14, 2012
Results First Submitted: February 4, 2015
Results First Posted: April 7, 2015
Last Update Posted: October 5, 2017