A phase III, multicentre, randomised, double-blind, placebo-controlled study with open-label follow on, to evaluate the efficacy, safety and tolerability of PSD502 [lidocaine/prilocaine] in subjects with Premature Ejaculation (PE)

Trial Profile

A phase III, multicentre, randomised, double-blind, placebo-controlled study with open-label follow on, to evaluate the efficacy, safety and tolerability of PSD502 [lidocaine/prilocaine] in subjects with Premature Ejaculation (PE)

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2016

At a glance

  • Drugs Lidocaine/prilocaine (Primary)
  • Indications Premature ejaculation
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 23 Sep 2013 Positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP), recommending EC approval for lidocaine/prilocaine, according to a Plethora Solutions Holdings media release.
    • 03 Jun 2010 Retrospective analysis reported at 105th Annual Meeting of the American Urological Association.
    • 03 Jun 2010 A pooled analysis of this and another pivotal phase III (700030634) trial has been presented at the 105th Annual Meeting of the American Urological Association.
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