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

Benign Prostatic Hyperplasia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00894517
• Other study ID #: 191622-091
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 5, 2009
• Last updated: July 30, 2013
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: July 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Biological:
• Botulinum Toxin Type A
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.

Drug:
• Placebo (saline)
Saline injected into the prostate on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 12	No
Secondary	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).	Baseline, Week 12	No
Secondary	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.	Baseline, Week 12	No
Secondary	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.	Baseline, Week 12	No
Secondary	Change From Baseline in Normal Sperm Morphology	Sperm Morphology was evaluated using the average of two semen samples collected 2 to 5 days apart at Baseline and at Week 12. Normal sperm morphology was assessed from slide smears sent to a central reading facility. A positive change from Baseline indicated improvement.	Baseline, Week 12	No