Trial Outcomes & Findings for H-22411: BOTOX® for Peyronie's Disease (NCT NCT00812838)
NCT ID: NCT00812838
Last Updated: 2024-04-08
Results Overview
Measured by a protractor from pictures taken at baseline (pre-treatment screening visit) and end of treatment at week 16 \*Crossover subjects were added to Experimental Group for analysis\* Negative value equates to a reduction in curvature Positive value equates to an increase in curvature
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16
Results posted on
2024-04-08
Participant Flow
Participant milestones
| Measure |
Experimental
100 units of Botulinum Toxin Type A Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
|
Placebo Comparator
Normal saline Injection solution will consist of 10 cc preservative free normal saline.
Optional Cross-over: For subjects in Arm 2, crossover to BOTOX treatment will begin after the Week 16 Visit by repeating the study schedule as for Week 0 to Week 16.
|
|---|---|---|
|
Treatment Period of 16 Weeks
STARTED
|
6
|
6
|
|
Treatment Period of 16 Weeks
COMPLETED
|
6
|
6
|
|
Treatment Period of 16 Weeks
NOT COMPLETED
|
0
|
0
|
|
Optional Crossover of 16 Weeks
STARTED
|
0
|
4
|
|
Optional Crossover of 16 Weeks
COMPLETED
|
0
|
4
|
|
Optional Crossover of 16 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
Baseline characteristics by cohort
| Measure |
Experimental
n=6 Participants
100 units of Botulinum Toxin Type A Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
\*Crossover subjects were added to Experimental Group for analysis\*
|
Placebo Comparator
n=6 Participants
Normal saline Injection solution will consist of 10 cc preservative free normal saline.
Optional Cross-over: For subjects in Arm 2, crossover to BOTOX treatment will begin after the Week 16 Visit by repeating the study schedule as for Week 0 to Week 16.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
6 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
12 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Age, Continuous
|
58.86 years
STANDARD_DEVIATION 4.741 • n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
57.83 years
STANDARD_DEVIATION 3.710 • n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
58.38 years
STANDARD_DEVIATION 4.154 • n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
6 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
12 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
6 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
12 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
1 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
1 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
5 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
11 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=7 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
0 Participants
n=5 Participants • Per the study protocol, two arms of the study are analyzed; the experimental arm and the placebo arm
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16Population: \*Crossover subjects were added to Experimental Group for analysis\*
Measured by a protractor from pictures taken at baseline (pre-treatment screening visit) and end of treatment at week 16 \*Crossover subjects were added to Experimental Group for analysis\* Negative value equates to a reduction in curvature Positive value equates to an increase in curvature
Outcome measures
| Measure |
Experimental
n=10 Participants
100 units of Botulinum Toxin Type A Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
|
Placebo Comparator
n=6 Participants
Normal saline Injection solution will consist of 10 cc preservative free normal saline
|
|---|---|---|
|
Average Percent Change of Penile Curvature in Degrees
|
-21.73 percent change
Standard Deviation 57.69
|
2.429 percent change
Standard Deviation 81.59
|
SECONDARY outcome
Timeframe: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16Population: \*Penile Doppler ultrasound was not performed on optional crossover patients. Data reflects scores derived from Experimental and Placebo group analysis.
Results of penile doppler ultrasound from baseline/screening visit to end of treatment at week 16 will be compared. peak systolic velocity (PSV) and end-diastolic velocity (EDV) are assessed here. Change is calculated as week 16 values - screening visit values Negative values are a decrease in velocity Positive values are an increase in velocity
Outcome measures
| Measure |
Experimental
n=6 Participants
100 units of Botulinum Toxin Type A Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
|
Placebo Comparator
n=6 Participants
Normal saline Injection solution will consist of 10 cc preservative free normal saline
|
|---|---|---|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
Pre injection Right PSV
|
-0.65670 cm/s
Standard Deviation 5.505
|
-9.0170 cm/s
Standard Deviation 11.43
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
Pre injection Right EDV
|
-2.10200 cm/s
Standard Deviation 6.798
|
-0.8667 cm/s
Standard Deviation 3.771
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
Pre injection Left PSV
|
-1.263 cm/s
Standard Deviation 9.032
|
-6.4330 cm/s
Standard Deviation 12.04
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
Pre injection Left EDV
|
-10.27 cm/s
Standard Deviation 8.261
|
-6.75 cm/s
Standard Deviation 11.63
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
5 minutes right PSV
|
5.185 cm/s
Standard Deviation 28.48
|
2.1330 cm/s
Standard Deviation 6.425
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
5 minutes right EDV
|
-11.05 cm/s
Standard Deviation 19.56
|
-0.1417 cm/s
Standard Deviation 3.944
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
5 minutes left psv
|
2.863 cm/s
Standard Deviation 17.68
|
-6.6830 cm/s
Standard Deviation 22.76
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
5 minutes left edv
|
-2.4 cm/s
Standard Deviation 10.80
|
3.5 cm/s
Standard Deviation 10.16
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
15 minutes right PSV
|
6.917 cm/s
Standard Deviation 20.91
|
-15.52 cm/s
Standard Deviation 34.44
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
15 minutes right EDV
|
-10.22 cm/s
Standard Deviation 22.82
|
1.55 cm/s
Standard Deviation 5.001
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
15 minutes left PSV
|
7.183 cm/s
Standard Deviation 10.81
|
-15.10 cm/s
Standard Deviation 40.93
|
|
Change in Penile Blood Flow for Peak Systolic Velocity (PSV) and End-diastolic Velocity (EDV)
15 minutes left EDV
|
-2.267 cm/s
Standard Deviation 11.58
|
3.367 cm/s
Standard Deviation 6.046
|
SECONDARY outcome
Timeframe: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16Population: \*Penile Doppler ultrasound was not performed on optional crossover patients. Data reflects scores derived from Experimental and Placebo group analysis.
Results of penile doppler ultrasound from the baseline/screening visit to end of treatment at week 16 will be compared. Diameter is assessed here. Change is calculated as week 16 values - screening visit values Negative values are a decrease in diameter Positive values are an increase in diameter
Outcome measures
| Measure |
Experimental
n=6 Participants
100 units of Botulinum Toxin Type A Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
|
Placebo Comparator
n=6 Participants
Normal saline Injection solution will consist of 10 cc preservative free normal saline
|
|---|---|---|
|
Change in Penile Blood Flow for Diameter
Pre injection left diameter
|
0.04167 cm
Standard Deviation 0.5869
|
0.3983 cm
Standard Deviation 0.4565
|
|
Change in Penile Blood Flow for Diameter
5 minute left diameter
|
-0.75330 cm
Standard Deviation 2.551
|
0.0750 cm
Standard Deviation 0.9000
|
|
Change in Penile Blood Flow for Diameter
Pre injection right Diameter
|
-0.29 cm
Standard Deviation 0.8539
|
0.1700 cm
Standard Deviation 0.7208
|
|
Change in Penile Blood Flow for Diameter
5 minute right diameter
|
1.34200 cm
Standard Deviation 4.006
|
0.2917 cm
Standard Deviation 0.6719
|
|
Change in Penile Blood Flow for Diameter
15 minute right diameter
|
-1.43700 cm
Standard Deviation 3.952
|
-0.3550 cm
Standard Deviation 0.6469
|
|
Change in Penile Blood Flow for Diameter
15 minute left diameter
|
-0.43500 cm
Standard Deviation 2.571
|
-0.1867 cm
Standard Deviation 1.203
|
SECONDARY outcome
Timeframe: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16Population: \*Crossover subjects were added to Experimental Group for analysis\*
Results of ultrasound at baseline/screening visit to end of treatment at week 16 will be compared. \*Crossover subjects were added to Experimental Group for analysis\* Change is calculated as week 16 values values minus screening visit values Increase in value equates to increased plaque size Decrease in value equates to decreased plaque size
Outcome measures
| Measure |
Experimental
n=10 Participants
100 units of Botulinum Toxin Type A Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
|
Placebo Comparator
n=6 Participants
Normal saline Injection solution will consist of 10 cc preservative free normal saline
|
|---|---|---|
|
Change in Penile Plaque Size
screening visit
|
717.5 cubic millimeters
Standard Deviation 827.4
|
485.8 cubic millimeters
Standard Deviation 599.6
|
|
Change in Penile Plaque Size
week 16
|
198.9 cubic millimeters
Standard Deviation 220.8
|
319.0 cubic millimeters
Standard Deviation 252.2
|
SECONDARY outcome
Timeframe: Baseline (Pre-Treatment Screening Visit) to end of treatment at week 16Population: \*Crossover subjects were added to Experimental Group for analysis\*
Subject's average scores on IIEF at baseline/screening visit to end of treatment at week 16 are compared The subscale measures self-reported erectile function. Maximum score is 30, Minimum is 0. A score of 0 is the absolute best outcome. A score of 30 is the absolute worst outcome. Erectile Function score is a summation of questions 1,2,3,4, and 15. This study is assessing their erectile function and not the other subscales. The other subscale scores are : 1. Orgasmic Function (Questions 9, 10); Maximum score = 10, Minimum score = 0 2. Sexual Desire (Questions 11, 12); Maximum score = 10, Minimum score = 0 3. Intercourse Satisfaction (Questions 6, 7, 8); Maximum score = 15, Minimum score = 0 4. Overall Satisfaction (Question 13, 14): Maximum score = 10, Minimum score = 0 Subscales are not combined to make a total composite score. \*Crossover subjects were added to Experimental Group for analysis\*
Outcome measures
| Measure |
Experimental
n=10 Participants
100 units of Botulinum Toxin Type A Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
|
Placebo Comparator
n=6 Participants
Normal saline Injection solution will consist of 10 cc preservative free normal saline
|
|---|---|---|
|
Changes in International Index of Erectile Function Scores (IIEF)
Screening Visit
|
15.60 score on a scale
Standard Deviation 11.75
|
21 score on a scale
Standard Deviation 12.13
|
|
Changes in International Index of Erectile Function Scores (IIEF)
Week 16
|
17.20 score on a scale
Standard Deviation 11.61
|
21.50 score on a scale
Standard Deviation 11.74
|
Adverse Events
100 Units of Botulinum Toxin Type A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
100 Units of Botulinum Toxin Type A
n=10 participants at risk
Injection solution will consist of 100 units of BOTOX® in 10 cc of preservative free normal saline
100 units of Botulinum Toxin Type A: Approximately 20 to 30 injections of 100 units of BOTOX® given with a 20 gage needle directly into the penile plaque
|
Normal Saline
n=6 participants at risk
Injection solution will consist of 10 cc preservative free normal saline
Preservative free normal saline: Approximately 20 to 30 injections of 10cc of preservative free normal saline given with a 20 gage needle directly into the penile plaque
|
|---|---|---|
|
Immune system disorders
Cold
|
20.0%
2/10 • Number of events 2 • 2 years, 8 months
|
0.00%
0/6 • 2 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
10.0%
1/10 • Number of events 1 • 2 years, 8 months
|
0.00%
0/6 • 2 years, 8 months
|
|
Vascular disorders
Bruising
|
20.0%
2/10 • Number of events 2 • 2 years, 8 months
|
0.00%
0/6 • 2 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Foot pain
|
10.0%
1/10 • Number of events 1 • 2 years, 8 months
|
0.00%
0/6 • 2 years, 8 months
|
|
Gastrointestinal disorders
small bowel obstruction
|
10.0%
1/10 • Number of events 1 • 2 years, 8 months
|
0.00%
0/6 • 2 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
seasonal allergies
|
10.0%
1/10 • Number of events 1 • 2 years, 8 months
|
0.00%
0/6 • 2 years, 8 months
|
|
Renal and urinary disorders
increased frequent urination
|
10.0%
1/10 • Number of events 1 • 2 years, 8 months
|
0.00%
0/6 • 2 years, 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place