Study of AA4500 in the Treatment of Peyronie's Disease

• 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: Endo Pharmaceuticals
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		AA4500	Placebo	Total
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
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

Outcome Measures

1. Primary Outcome

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 52

Outcome Measure Data

Analysis Population Description

Efficacy is based on the modified intent-to-treat population (mITT).

Arm/Group Title	AA4500	Placebo
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)

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)
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

Outcome Measure Data

Analysis Population Description

Efficacy is based on the mITT population.

Arm/Group Title	AA4500	Placebo
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)

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
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

Outcome Measure Data

Analysis Population Description

Efficacy analysis was based on the mITT population.

Arm/Group Title	AA4500	Placebo
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

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
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

Outcome Measure Data

Analysis Population Description

Efficacy analysis is based on the mITT population.

Arm/Group Title	AA4500	Placebo
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)

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)
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

Outcome Measure Data

Analysis Population Description

Efficacy analysis is based on the mITT population.

Arm/Group Title	AA4500	Placebo
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)

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
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

Outcome Measure Data

Analysis Population Description

Efficacy analysis is based on the mITT population.

Arm/Group Title	AA4500	Placebo
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)

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
Description	A negative value represents a reduction in measurement from baseline.
Time Frame	Baseline and Week 52

Outcome Measure Data

Analysis Population Description

Efficacy analysis is based on the mITT population.

Arm/Group Title	AA4500	Placebo
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)

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
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

Outcome Measure Data

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
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)

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
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

Outcome Measure Data

Analysis Population Description

Efficacy analysis is based on the mITT population.

Arm/Group Title	AA4500	Placebo
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

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]

Adverse Events

Time Frame	Throughout the study
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	AA4500		Placebo
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	--/--		--/--
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)
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)

Limitations and Caveats

[Not Specified]

More Information

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.
• EMail: clinicalsite.inquiries@endo.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hellstrom WJ, Feldman RA, Coyne KS, Kaufman GJ, Smith TM, Tursi JP, Rosen RC. Self-report and Clinical Response to Peyronie's Disease Treatment: Peyronie's Disease Questionnaire Results From 2 Large Double-Blind, Randomized, Placebo-Controlled Phase 3 Studies. Urology. 2015 Aug;86(2):291-8. doi: 10.1016/j.urology.2015.04.047. Epub 2015 Jul 18.

• Responsible Party: Endo Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01221597
• 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