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A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms

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Trial Profile

A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Feb 2017

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At a glance

  • Drugs Estradiol (Primary)
  • Indications Atrophic vaginitis
  • Focus Therapeutic Use
  • Sponsors Novo Nordisk

Most Recent Events

  • 02 Dec 2009 According to a Novo Nordisk media release, US FDA approval of vagifem was based on the results of this trial.
  • 16 Jun 2009 Actual end date (Mar 2007) added as reported by ClinicalTrials.gov.
  • 25 Nov 2008 New trial record.

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