Second US pivotal phase III, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of topical alprostadil in patients with mild to severe erectile dysfunction

Trial Profile

Second US pivotal phase III, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of topical alprostadil in patients with mild to severe erectile dysfunction

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Apr 2016

At a glance

  • Drugs Alprostadil (Primary)
  • Indications Erectile dysfunction
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 06 Apr 2016 According to an Apricus Biosciences media release, the company is planning resubmission of NDA for topical alprostadil for erectile dysfunction with the US FDA in the third quarter of 2016, and is expecting potential approval in first half of 2017.
    • 09 Mar 2016 According to an Apricus Biosciences media release, the company had filed an NDA for topical alprostadil for ED with the US FDA in September 2007 and is planning resubmission of NDA in the second half of 2016.
    • 13 May 2013 New trial record
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