Status:
COMPLETED
A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
Lead Sponsor:
Allergan
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45-70 years
Phase:
PHASE1
PHASE2
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).
Eligibility Criteria
Inclusion
- Symptoms due to an enlarged prostate
- Able to provide semen samples at required visits.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00894517
Start Date
August 1 2009
End Date
August 1 2012
Last Update
September 30 2013
Active Locations (1)
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1
Los Angeles, California, United States