A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia

Study Identifier
191622-091
CT.gov Identifier
NCT00894517
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Men's Health
    • Study Drug
  • Botulinum Toxin Type A
  • Placebo (saline)
    • Phase
    Phase 1/Phase 2
    Sex
    Male
    Age
    45 - 70 Years
    Inclusion and Exclusion 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

    Protocol 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).

    Study Locations

    Location
    Status
    Location
    Los Angeles, California, United States
    Status
    Not applicable