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)
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History