Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)

Trial Profile

Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of a Single Intraprostatic Treatment of PRX302 for Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (The PLUS 1 Trial)

Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2017

At a glance

  • Drugs Topsalysin (Primary)
  • Indications Benign prostatic hyperplasia; Lower urinary tract symptoms
  • Focus Registrational; Therapeutic Use
  • Acronyms PLUS-1
  • Sponsors Sophiris Bio
  • Most Recent Events

    • 17 May 2016 Status changed from active, no longer recruiting to completed, as reported by Sophiris Bio media release.
    • 16 May 2016 According to Sophiris Bio media release, positive data presented at the 111th American Urological Association Annual Meeting.
    • 10 May 2016 Results presented at the 111th Annual Meeting of the American Urological Association
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