CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 380 enrolled
Drug / intervention
botulinum toxin Type A +1 morebiological
Likely dose
Botulinum toxin Type A 100 U, 200 U, or 300 U transperineal or transrectal injection on Day 1AI-extracted
Key inclusion· 2
  • ✓Lower urinary tract symptoms due to benign prostatic hyperplasia
  • ✓Enlarged prostate volume confirmed by rectal ultrasound
Key exclusion· 4
  • ✕Previous prostate surgery
  • ✕Previous or current diagnosis of prostate cancer
  • ✕Current use of medications for treatment of prostatic hyperplasia
  • ✕Active urinary tract infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00284518
NCT00284518Phase 2Completed
CompareCT.gov

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

Allergan·interventional·Posted Feb 1, 2006·Updated Dec 17, 2012

In Brief

A Phase 2 clinical trial evaluating botulinum toxin Type A and normal saline for Benign Prostatic Hyperplasia. Completed, enrolled 380 participants across 11 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBenign Prostatic Hyperplasia
CountriesAustralia, Austria, Canada, Czechia, France, Germany, Italy, Slovakia, South Korea, Taiwan, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 1, 2006
Enrollment StartDec 1, 2005
Primary CompletionMay 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.4 years ago

Interventions

botulinum toxin Type Abiological

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

normal salinedrug

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