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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00894517

Enrollment

Registered

2009-05-07

Start date

2009-08-31

Completion date

2012-08-31

Last updated

2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia

Brief 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).

Interventions

BIOLOGICALBotulinum Toxin Type A

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

DRUGPlacebo (saline)

Saline injected into the prostate on Day 1.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

45 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percent Change in Total Sperm Count Per Ejaculate	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

Measure	Time frame	Description
Change From Baseline in Log Transformed Sperm Concentration	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	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	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	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Botulinum Toxin Type A OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.	30
Placebo (Normal Saline) Placebo (Normal saline) injected into the prostate on Day 1.	31
Total	61

Baseline characteristics

Characteristic	Botulinum Toxin Type A	Placebo (Normal Saline)	Total
Age, Customized 45 to 60 years	20 Participants	25 Participants	45 Participants
Age, Customized > 60 years	10 Participants	6 Participants	16 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	30 Participants	31 Participants	61 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	18 / 29	12 / 30
serious Total, serious adverse events	0 / 29	3 / 30

Outcome results

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.

Time frame: Baseline, Week 12