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Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

NCT01107392 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2019-05-03

Study results available
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Summary

This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

botulinum toxin Type A

botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.

DRUG

Normal saline

Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-01
Primary Completion
2012-03-16
Completion
2012-06-08

Countries

  • United States
  • Canada
  • Czechia
  • France
  • Germany
  • Philippines
  • Poland
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01107392 on ClinicalTrials.gov