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Trial record 21 of 117 for:    "Penile Disease"

Study of AA4500 in the Treatment of Peyronie's Disease

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ClinicalTrials.gov Identifier: NCT01221597
Recruitment Status : Completed
First Posted : October 15, 2010
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 Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Peyronie's Disease
Interventions Biological: AA4500
Biological: Placebo
Enrollment 418
Recruitment Details  
Pre-assignment Details Includes all subjects who were randomized and received at least 1 dose of study drug; subjects who were randomized but not treated were excluded from the population
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description

collagenase clostridium histolyticum

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.

placebo: 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.
Period Title: Overall Study
Started 277 140
Completed 241 124
Not Completed 36 16
Reason Not Completed
Adverse Event             4             1
Withdrawal by Subject             20             6
Lost to Follow-up             6             5
Protocol Violation             1             0
Other             3             4
Death             2             0
Arm/Group Title AA4500 Placebo Total
Hide Arm/Group Description

collagenase clostridium histolyticum

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.

Placebo: 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. Total of all reporting groups
Overall Number of Baseline Participants 277 140 417
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 277 participants 140 participants 417 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
226
  81.6%
108
  77.1%
334
  80.1%
>=65 years
51
  18.4%
32
  22.9%
83
  19.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 277 participants 140 participants 417 participants
57.9  (8.22) 58.2  (8.94) 58.0  (8.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 277 participants 140 participants 417 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
277
 100.0%
140
 100.0%
417
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 277 participants 140 participants 417 participants
United States 223 113 336
Australia 54 27 81
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 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the modified intent-to-treat population (mITT).
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

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.

Placebo: 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.
Overall Number of Participants Analyzed 199 104
Mean (Standard Deviation)
Unit of Measure: percentage of curvature change
-37.6  (30.29) -21.3  (29.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
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 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

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.

Placebo: 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.
Overall Number of Participants Analyzed 199 104
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.3  (3.83) -2.0  (3.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0451
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease
Hide Description A responder was defined as a subject who recorded his Peyronie’s disease had either improved in a small but important way, moderately improved, or much improved in overall global assessment question.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

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.

placebo: 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.
Overall Number of Participants Analyzed 199 104
Measure Type: Number
Unit of Measure: Number of particpants
Responder Status-No 67 73
Responder Status-Yes 131 30
Responder Status-Missing 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Severity of Peyronie's Disease Physical and Psychological Symptoms
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 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

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.

placebo: 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.
Overall Number of Participants Analyzed 199 104
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.2  (5.23) -1.6  (4.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0268
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.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 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

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.

placebo: 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.
Overall Number of Participants Analyzed 199 104
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.0  (2.55) 0.5  (2.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0800
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.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 score in penile plaque consistency is indicated by a negative number.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

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.

placebo: 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.
Overall Number of Participants Analyzed 199 104
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7  (0.97) -0.6  (0.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3085
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.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 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

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.

placebo: 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.
Overall Number of Participants Analyzed 199 104
Mean (Standard Deviation)
Unit of Measure: centimeters
0.4  (1.29) 0.1  (1.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6321
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.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 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis 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 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

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.

placebo: 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.
Overall Number of Participants Analyzed 77 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.1  (5.16) -4.0  (4.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7965
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Composite Responder Based on Change in Curvature Deformity and Change in Peyronie's Disease Bother Score
Hide Description A responder was defined as a subject who satisfied the following 2 criteria at that visit: a) percent reduction from baseline in curvature deformity was ≥20% and b) reduction from baseline in PDQ Peyronie’s disease bother score was ≥1, or had a change from reporting no sexual activity at screening to reporting sexual activity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

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.

placebo: 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.
Overall Number of Participants Analyzed 277 140
Measure Type: Number
Unit of Measure: Number of participants
Responder Status No 129 97
Responder Status yes 132 33
Responder- Missing 16 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame Throughout the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description

collagenase clostridium histolyticum

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.

Placebo: 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.
All-Cause Mortality
AA4500 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AA4500 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/277 (9.75%)      7/140 (5.00%)    
Blood and lymphatic system disorders     
Anaemia  1  1/277 (0.36%)  1 0/140 (0.00%)  0
Cardiac disorders     
Atrial fibrillation * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Gastrointestinal disorders     
Mesenteric artery stenosis * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Colitis ulcerative * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Pancreatitis * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Intestinal performation * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Diverticulum * 1  0/277 (0.00%)  0 1/140 (0.71%)  1
General disorders     
Drug withdrawal syndrome * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Chest pain * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Hepatobiliary disorders     
Cholelithiasis * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Cholecystitis * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Infections and infestations     
Appendicitis * 1  0/277 (0.00%)  0 1/140 (0.71%)  1
Injury, poisoning and procedural complications     
Road traffic accident * 1  2/277 (0.72%)  2 0/140 (0.00%)  0
Fracture of penis * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Rib fracture * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Traumatic lung injury * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Spinal compression fracture * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Post laminectomy syndrome * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Incisional hernia * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Clavicle fracture * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoarthritis * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Arthritis * 1  0/277 (0.00%)  0 1/140 (0.71%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder transitional cell carcinoma * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Malignant melanoma * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Basal cell carcinoma * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Squamous cell carcinoma * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Prostate cancer * 1  2/277 (0.72%)  2 1/140 (0.71%)  1
B cell lymphoma * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Lung cancer metastatic * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Hodgkin's disease * 1  0/277 (0.00%)  0 1/140 (0.71%)  1
Carcinoma in situ penis * 1  0/277 (0.00%)  0 1/140 (0.71%)  1
Nervous system disorders     
Grand mal convulsion * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Transient ischemic attack * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Sciatica * 1  1/277 (0.36%)  1 1/140 (0.71%)  1
Reproductive system and breast disorders     
Penile hematoma * 1  2/277 (0.72%)  2 0/140 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  3/277 (1.08%)  3 0/140 (0.00%)  0
Pleuritic pain * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Chronic obstructive pulmonary disease * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Vascular disorders     
Orthostatic hypotension * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Deep vein thrombosis * 1  1/277 (0.36%)  1 0/140 (0.00%)  0
Indicates events were collected by systematic assessment
*
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 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   248/277 (89.53%)      55/140 (39.29%)    
General disorders     
Injection site pain * 1  70/277 (25.27%)  127 5/140 (3.57%)  12
injection site haematoma * 1  45/277 (16.25%)  66 14/140 (10.00%)  18
Injection site swelling * 1  30/277 (10.83%)  47 0/140 (0.00%)  0
Injection site haemorrhage * 1  15/277 (5.42%)  24 10/140 (7.14%)  16
Infections and infestations     
Upper respiratory tract infection * 1  9/277 (3.25%)  9 7/140 (5.00%)  7
Injury, poisoning and procedural complications     
Contusion * 1  28/277 (10.11%)  40 0/140 (0.00%)  0
Reproductive system and breast disorders     
Penile haematoma * 1  171/277 (61.73%)  394 19/140 (13.57%)  31
Penile pain * 1  119/277 (42.96%)  244 11/140 (7.86%)  15
Penile swelling * 1  114/277 (41.16%)  219 1/140 (0.71%)  1
Penile haemorrhage * 1  60/277 (21.66%)  181 14/140 (10.00%)  19
Penile oedema * 1  45/277 (16.25%)  98 1/140 (0.71%)  1
Skin and subcutaneous tissue disorders     
Ecchymosis * 1  26/277 (9.39%)  39 0/140 (0.00%)  0
*
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
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals, Inc.
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01221597     History of Changes
Other Study ID Numbers: AUX-CC-803
First Submitted: October 8, 2010
First Posted: October 15, 2010
Results First Submitted: February 4, 2015
Results First Posted: April 7, 2015
Last Update Posted: October 5, 2017