Back to resultsA Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
Primary Purpose
Benign Prostatic Hyperplasia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Placebo (saline)
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Symptoms due to an enlarged prostate
- Able to provide semen samples at required visits.
Exclusion Criteria:
- Previous use of any botulinum toxin for the treatment of any urological condition
- History of vasectomy
- History of undescended testicles or testicular trauma
- Subject who has not ejaculated for greater than 1 year
- History of prostate infection or any sexually transmitted disease, such as gonorrhea, within the previous 12 months
- History of bladder stones
- History of cancer in the prostate, testicles, or bladder
- Previous use of chemotherapy for cancer treatment
- History of urinary incontinence
- Previous prostate surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Botulinum Toxin Type A
Placebo (saline)
Arm Description
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
Placebo (saline) injected into the prostate on Day 1.
Outcomes
Primary Outcome Measures
Percent Change in Total Sperm Count Per Ejaculate
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.
Secondary Outcome Measures
Change From Baseline in Log Transformed Sperm Concentration
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).
Change From Baseline in Ejaculatory Volume
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.
Change From Baseline in Total Sperm Motility
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.
Change From Baseline in Normal Sperm Morphology
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00894517
Brief Title
A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 24 week study evaluating the effects of botulinum toxin Type A on semen quality in patients with signs and symptoms of Benign Prostatic Hyperplasia (BPH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum Toxin Type A
Arm Type
Experimental
Arm Description
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
Arm Title
Placebo (saline)
Arm Type
Placebo Comparator
Arm Description
Placebo (saline) injected into the prostate on Day 1.
Intervention Type
Biological
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
BOTOX®
Intervention Description
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
Intervention Type
Drug
Intervention Name(s)
Placebo (saline)
Intervention Description
Saline injected into the prostate on Day 1.
Primary Outcome Measure Information:
Title
Percent Change in Total Sperm Count Per Ejaculate
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Log Transformed Sperm Concentration
Description
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).
Time Frame
Baseline, Week 12
Title
Change From Baseline in Ejaculatory Volume
Description
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.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Total Sperm Motility
Description
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.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Normal Sperm Morphology
Description
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.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptoms due to an enlarged prostate
Able to provide semen samples at required visits.
Exclusion Criteria:
Previous use of any botulinum toxin for the treatment of any urological condition
History of vasectomy
History of undescended testicles or testicular trauma
Subject who has not ejaculated for greater than 1 year
History of prostate infection or any sexually transmitted disease, such as gonorrhea, within the previous 12 months
History of bladder stones
History of cancer in the prostate, testicles, or bladder
Previous use of chemotherapy for cancer treatment
History of urinary incontinence
Previous prostate surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
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