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A double-blind, randomized, placebo-and active-controlled efficacy and safety study of bazedoxifene/conjugated estrogens combinations for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women

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Trial Profile

A double-blind, randomized, placebo-and active-controlled efficacy and safety study of bazedoxifene/conjugated estrogens combinations for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2017

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At a glance

  • Drugs Conjugated estrogens/bazedoxifene (Primary) ; Bazedoxifene
  • Indications Atrophic vaginitis; Female sexual dysfunction
  • Focus Registrational; Therapeutic Use
  • Acronyms SMART-3
  • Sponsors Wyeth

    • Most Recent Events

    • 08 Oct 2016 Pooled post hoc analysis results of SMART-1 (NCT00675688), SMART-2 (NCT00234819), SMART-3 (NCT00238732), SMART-4 (NCT00242710), and SMART-5 (NCT00808132) presented at the 27th North American Menopause Society
    • 09 Feb 2015 According to a Ligand Pharmaceuticals media release, Pfizer received EU marketing approval for DUAVIVE based on the data from this study.
    • 12 Oct 2013 Pooled tolerability results presented at the 24th Annual Meeting of the North American Menopause Society.

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