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Completed

NCT Number: NCT00894517

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

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).

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

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

Other names: BOTOX®

Placebo (saline)

Drug

Saline injected into the prostate on Day 1.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 7, 2009
Registry last updated
Sep 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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