Phase 2
Completed N=61
A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia
Source: ClinicalTrials.gov NCT00894517 ↗Enrolled (actual)
61
Serious AEs
5.1%
Results posted
Sep 2013
Primary outcomePrimary: Percent Change in Total Sperm Count Per Ejaculate — 3.62; -12.22 Percent change
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Total Sperm Count Per Ejaculate |
3.62; -12.22 | — |
| SECONDARY Change From Baseline in Log Transformed Sperm Concentration |
3.77; 3.82; -0.13; -0.23 | — |
| SECONDARY Change From Baseline in Ejaculatory Volume |
2.30; 2.35; -0.12; -0.09 | — |
| SECONDARY Change From Baseline in Total Sperm Motility |
53.67; 55.15; -1.50; -3.93 | — |
| SECONDARY Change From Baseline in Normal Sperm Morphology |
12.37; 14.14; 0.36; 0.05 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00894517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.