Trial Outcomes & Findings for A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia (NCT NCT00894517)
NCT ID: NCT00894517
Last Updated: 2013-09-30
Results Overview
Sperm count per ejaculate was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume and sperm concentration were used to determine the total sperm count per ejaculate. A positive percent change from Baseline indicated improvement.
COMPLETED
PHASE1/PHASE2
61 participants
Baseline, Week 12
2013-09-30
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
|
Placebo (Normal Saline)
Placebo (Normal saline) injected into the prostate on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A
n=30 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
|
Placebo (Normal Saline)
n=31 Participants
Placebo (Normal saline) injected into the prostate on Day 1.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
45 to 60 years
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Customized
> 60 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Safety population included all randomized participants who received treatment.
Sperm count per ejaculate was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume and sperm concentration were used to determine the total sperm count per ejaculate. A positive percent change from Baseline indicated improvement.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=29 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
|
Placebo (Normal Saline)
n=30 Participants
Placebo (Normal saline) injected into the prostate on Day 1.
|
|---|---|---|
|
Percent Change in Total Sperm Count Per Ejaculate
|
3.62 Percent change
Standard Deviation 56.773
|
-12.22 Percent change
Standard Deviation 57.564
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Safety population included all randomized participants who received treatment.
Sperm concentration was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Collected sperm samples were assessed using a CELL-VU® count chamber. The total number of sperm per 100 boxes on the chamber grid were counted. Sperm Concentration = total number of sperm counted in 100 boxes × dilution factor / 1 × 10\^6 and is reported in millions per milliliter. Log transformation of the sperm concentration was used for analysis . The log transformed sperm concentration data has no units. A negative change from Baseline indicated a lower sperm concentration (worsening).
Outcome measures
| Measure |
Botulinum Toxin Type A
n=29 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
|
Placebo (Normal Saline)
n=30 Participants
Placebo (Normal saline) injected into the prostate on Day 1.
|
|---|---|---|
|
Change From Baseline in Log Transformed Sperm Concentration
Baseline
|
3.77 Unitless
Standard Deviation 0.765
|
3.82 Unitless
Standard Deviation 0.814
|
|
Change From Baseline in Log Transformed Sperm Concentration
Change from Baseline at Week 12 (n=29, 27)
|
-0.13 Unitless
Standard Deviation 0.599
|
-0.23 Unitless
Standard Deviation 0.457
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Safety population included all randomized participants who received treatment.
Ejaculatory volume was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume was measured using a standard pipette (measuring device). A negative change from Baseline indicated worsening.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=29 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
|
Placebo (Normal Saline)
n=30 Participants
Placebo (Normal saline) injected into the prostate on Day 1.
|
|---|---|---|
|
Change From Baseline in Ejaculatory Volume
Baseline
|
2.30 milliliters (mL)
Standard Deviation 1.170
|
2.35 milliliters (mL)
Standard Deviation 1.267
|
|
Change From Baseline in Ejaculatory Volume
Change from Baseline at Week 12 (n=29, 28)
|
-0.12 milliliters (mL)
Standard Deviation 0.813
|
-0.09 milliliters (mL)
Standard Deviation 0.690
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Safety population included all randomized participants who received treatment.
Sperm motility was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Sperm motility was assessed using the CELL-VU chamber and was scored according to the World Health Organization criteria for sperm progression and motility. A total of at least 200 motile and immotile sperm were counted. A percent was determined by the calculation of motile sperm/total sperm count. A negative change from Baseline indicated a worsening.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=29 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
|
Placebo (Normal Saline)
n=30 Participants
Placebo (Normal saline) injected into the prostate on Day 1.
|
|---|---|---|
|
Change From Baseline in Total Sperm Motility
Baseline
|
53.67 Percent
Standard Deviation 14.214
|
55.15 Percent
Standard Deviation 11.519
|
|
Change From Baseline in Total Sperm Motility
Change from Baseline at Week 12 (n=29, 28)
|
-1.50 Percent
Standard Deviation 13.142
|
-3.93 Percent
Standard Deviation 14.167
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Safety population included all randomized participants who received treatment.
Sperm Morphology was evaluated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Normal sperm morphology was assessed from slide smears sent to a central reading facility. A positive change from Baseline indicated improvement.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=29 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
|
Placebo (Normal Saline)
n=30 Participants
Placebo (Normal saline) injected into the prostate on Day 1.
|
|---|---|---|
|
Change From Baseline in Normal Sperm Morphology
Baseline
|
12.37 Percent
Standard Deviation 3.503
|
14.14 Percent
Standard Deviation 2.989
|
|
Change From Baseline in Normal Sperm Morphology
Change from Baseline at Week 12 (n=29, 28)
|
0.36 Percent
Standard Deviation 0.852
|
0.05 Percent
Standard Deviation 1.240
|
Adverse Events
Botulinum Toxin Type A
Placebo (Normal Saline)
Serious adverse events
| Measure |
Botulinum Toxin Type A
n=29 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
|
Placebo (Normal Saline)
n=30 participants at risk
Placebo (Normal saline) injected into the prostate on Day 1.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.3%
1/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.3%
1/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.3%
1/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.3%
1/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.3%
1/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.3%
1/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.3%
1/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Other adverse events
| Measure |
Botulinum Toxin Type A
n=29 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
|
Placebo (Normal Saline)
n=30 participants at risk
Placebo (Normal saline) injected into the prostate on Day 1.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
13.8%
4/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
3.3%
1/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Haematuria
|
6.9%
2/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.7%
2/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Nephrolithiasis
|
6.9%
2/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
6.7%
2/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Dysuria
|
6.9%
2/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Renal and urinary disorders
Micturition urgency
|
6.9%
2/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Reproductive system and breast disorders
Haematospermia
|
13.8%
4/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
23.3%
7/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
|
Reproductive system and breast disorders
Ejaculation delayed
|
6.9%
2/29
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
0.00%
0/30
The safety population (all randomized and treated participants) was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER