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

Allergan61 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Benign Prostatic Hyperplasia

Interventions

Botulinum Toxin Type ABIOLOGICAL

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

Placebo (saline)DRUG

Saline injected into the prostate on Day 1.

Eligibility

Sex: MALEMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Los Angeles, California, United States

Outcomes

Primary Outcomes

Percent Change in Total Sperm Count Per Ejaculate

Sperm count per ejaculate was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume and sperm concentration were used to determine the total sperm count per ejaculate. A positive percent change from Baseline indicated improvement.

Time frame: Baseline, Week 12

Secondary Outcomes

Change From Baseline in Log Transformed Sperm Concentration

Sperm concentration was calculated based on the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Collected sperm samples were assessed using a CELL-VU® count chamber. The total number of sperm per 100 boxes on the chamber grid were counted. Sperm Concentration = total number of sperm counted in 100 boxes × dilution factor / 1 × 10\^6 and is reported in millions per milliliter. Log transformation of the sperm concentration was used for analysis . The log transformed sperm concentration data has no units. A negative change from Baseline indicated a lower sperm concentration (worsening).

Time frame: Baseline, Week 12

Change From Baseline in Ejaculatory Volume

Ejaculatory volume was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Ejaculatory volume was measured using a standard pipette (measuring device). A negative change from Baseline indicated worsening.

Time frame: Baseline, Week 12

Change From Baseline in Total Sperm Motility

Sperm motility was calculated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Sperm motility was assessed using the CELL-VU chamber and was scored according to the World Health Organization criteria for sperm progression and motility. A total of at least 200 motile and immotile sperm were counted. A percent was determined by the calculation of motile sperm/total sperm count. A negative change from Baseline indicated a worsening.

Data from ClinicalTrials.gov

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