A multicenter, double blind, randomized, placebo-controlled, dose-response study to evaluate the safety and efficacy of a single treatment of Botox (Botulinum Toxin Type A) purified neurotoxin complex injected into the prostate for the treatment of lower urinary tract symptoms in patients due to benign prostatic hyperplasia. [Studio dose-risposta multicentrico, in doppio cieco, randomizzato, controllato con placebo per valutare la tollerabilita` e la sicurezza di una singola somministrazione di BOTOX (tossina botulinica di tipo A), complesso di neurotossina purificata iniettato nella prostata per il trattamento dei sintomi del tratto urinario inferiore in pazienti con Iperplasia Prostatica Benigna]

Trial Profile

A multicenter, double blind, randomized, placebo-controlled, dose-response study to evaluate the safety and efficacy of a single treatment of Botox (Botulinum Toxin Type A) purified neurotoxin complex injected into the prostate for the treatment of lower urinary tract symptoms in patients due to benign prostatic hyperplasia. [Studio dose-risposta multicentrico, in doppio cieco, randomizzato, controllato con placebo per valutare la tollerabilita` e la sicurezza di una singola somministrazione di BOTOX (tossina botulinica di tipo A), complesso di neurotossina purificata iniettato nella prostata per il trattamento dei sintomi del tratto urinario inferiore in pazienti con Iperplasia Prostatica Benigna]

Completed
Phase of Trial: Phase II

Latest Information Update: 22 Apr 2017

At a glance

  • Drugs Botulinum toxin A (Primary)
  • Indications Benign prostatic hyperplasia; Lower urinary tract symptoms
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 17 May 2012 Actual end date (May 2010) added as reported by ClinicalTrials.gov.
    • 17 May 2012 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 27 Feb 2009 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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