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

Allergan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Benign Prostatic Hyperplasia

Treatments: Biological: Botulinum Toxin Type A; Drug: Placebo (saline)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00894517

191622-091

Details and patient eligibility

About

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).

Enrollment: 61 patients

Sex: Male

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups, including a placebo group

Botulinum Toxin Type A

Experimental group

Description:

OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.

Treatment:

Biological: Botulinum Toxin Type A

Placebo (saline)

Placebo Comparator group

Description:

Placebo (saline) injected into the prostate on Day 1.

Treatment:

Drug: Placebo (saline)