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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:
ClinicalTrials.gov Identifier:
NCT00894517
First Posted: May 7, 2009
Last Update Posted: September 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894517


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00894517     History of Changes
Other Study ID Numbers: 191622-091
First Submitted: May 5, 2009
First Posted: May 7, 2009
Results First Submitted: July 30, 2013
Results First Posted: September 30, 2013
Last Update Posted: September 30, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents