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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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