A Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled Study, With Open-label Follow on, to Evaluate the Efficacy, Safety and Tolerability of PSD502 in Subjects With Premature Ejaculation (PE).

Trial Profile

A Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled Study, With Open-label Follow on, to Evaluate the Efficacy, Safety and Tolerability of PSD502 in Subjects With Premature Ejaculation (PE).

Completed
Phase of Trial: Phase II/III

Latest Information Update: 30 Sep 2016

At a glance

  • Drugs Lidocaine/prilocaine (Primary)
  • Indications Premature ejaculation
  • Focus Registrational; Therapeutic Use
  • Sponsors Plethora Solutions
  • 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.
    • 29 Jul 2009 Primary endpoint 'Intravaginal ejaculatory latency time' has been met.
    • 30 Mar 2009 New source identified and integrated (ISRCTN 57186091).
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