A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
ClinicalTrials.gov ID
NCT00894517
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1Phase 2
Enrollment
61Actual
Last Update Posted
Sep 30, 2013Estimated
Start Date
Aug 2009
Primary Completion Date
Jun 2012Actual
Completion Date
Aug 2012Actual
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).
Benign Prostatic Hyperplasia
Botulinum Toxin Type A
Placebo (saline)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Male
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