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

NCT00284518 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2012-12-17

Study results available
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Summary

The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

BIOLOGICAL

botulinum toxin Type A

Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.

DRUG

normal saline

Normal Saline (Placebo) transperineal or transrectal injection on Day 1.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2009-05-31
Completion
2010-05-31

Countries

  • Australia
  • Austria
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Slovakia
  • South Korea
  • Taiwan
  • United Kingdom

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 NCT00284518 on ClinicalTrials.gov