A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women

Trial Profile

A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2016

At a glance

  • Drugs Conjugated estrogens/bazedoxifene (Primary) ; Bazedoxifene; Conjugated estrogens/medroxyprogesterone
  • Indications Menopausal syndrome; Postmenopausal osteoporosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SMART-5
  • Sponsors Pfizer; Wyeth
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 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.
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