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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00894517
First received: May 5, 2009
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Benign Prostatic Hyperplasia
Biological: Botulinum Toxin Type A
Drug: Placebo (saline)
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percent Change in Total Sperm Count Per Ejaculate [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Log Transformed Sperm Concentration [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Ejaculatory Volume [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Total Sperm Motility [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Normal Sperm Morphology [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 61
Study Start Date: August 2009
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum Toxin Type A
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
Biological: Botulinum Toxin Type A
OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
Other Name: BOTOX®
Placebo Comparator: Placebo (saline)
Placebo (saline) injected into the prostate on Day 1.
Drug: Placebo (saline)
Saline injected into the prostate on Day 1.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894517

Locations
United States, California
Los Angeles, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00894517     History of Changes
Other Study ID Numbers: 191622-091
Study First Received: May 5, 2009
Results First Received: July 30, 2013
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014