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An Investigator-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, USP 10 Mcg and Vagifem (Estradiol Vaginal Tablets) 10 Mcg and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause

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Trial Profile

An Investigator-Blind, Randomized, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, USP 10 Mcg and Vagifem (Estradiol Vaginal Tablets) 10 Mcg and Compare Both Active Treatments to a Placebo Control in Female Subjects With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy Associated With Menopause

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2021

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At a glance

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

    • Most Recent Events

    • 26 Jun 2014 Biomarkers information updated
    • 07 Feb 2013 New trial record

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