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