A Phase 2, Dose-ranging, 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005% Estriol Vaginal Gel, 0.002% Estriol Vaginal Gel, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women with Vulvovaginal Atrophy.

Trial Profile

A Phase 2, Dose-ranging, 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Three Formulations of Ultra-low Dose Estriol Vaginal Gel (0.005% Estriol Vaginal Gel, 0.002% Estriol Vaginal Gel, 0.0008% Estriol Vaginal Gel) for the Treatment of Vaginal Dryness in Postmenopausal Women with Vulvovaginal Atrophy.

Recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Oct 2017

At a glance

  • Drugs Estriol succinate (Primary)
  • Indications Atrophic vaginitis
  • Focus Therapeutic Use
  • Sponsors Itf Research Pharma
  • Most Recent Events

    • 06 Oct 2017 Planned End Date changed from 1 Dec 2017 to 1 May 2018.
    • 06 Oct 2017 Planned primary completion date changed from 1 Nov 2017 to 1 Apr 2018.
    • 09 Sep 2016 New trial record
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