A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine; and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects Following Daily Application to the Vagina and Cervix for Seven Days With Three Different Doses of PSD502 or Placebo.

Trial Profile

A Phase I, Single-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Pharmacokinetic and Safety Study to Evaluate Systemic Exposure and Local Vaginal Exposure to Lidocaine and Prilocaine and the Metabolites 2,6 DiMethylAlanine (2, 6, DMA) and O-Toluidine; and the Safety and Tolerability of PSD502 in Female Healthy Volunteer Subjects Following Daily Application to the Vagina and Cervix for Seven Days With Three Different Doses of PSD502 or Placebo.

Completed
Phase of Trial: Phase I

Latest Information Update: 11 Aug 2016

At a glance

  • Drugs Lidocaine/prilocaine (Primary)
  • Indications Premature ejaculation
  • Focus Adverse reactions
  • Sponsors Shionogi Pharma
  • Most Recent Events

    • 12 Jul 2011 Actual initiation date changed from Jan 2010 to Dec 2009 as reported by ClinicalTrials.gov.
    • 04 Sep 2010 New trial record
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