A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
NCT ID: NCT00894517
Last Updated: 2013-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2009-08-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Botulinum Toxin Type A
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
Botulinum Toxin Type A
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
Placebo (saline)
Placebo (saline) injected into the prostate on Day 1.
Placebo (saline)
Saline injected into the prostate on Day 1.
Interventions
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Botulinum Toxin Type A
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
Placebo (saline)
Saline injected into the prostate on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to provide semen samples at required visits.
Exclusion Criteria
* 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
45 Years
70 Years
MALE
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Los Angeles, California, United States
Countries
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Other Identifiers
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191622-091
Identifier Type: -
Identifier Source: org_study_id