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A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus

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Trial Profile

A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Mar 2022

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At a glance

  • Drugs Estradiol/progesterone (Primary)
  • Indications Menopausal syndrome; Vasomotor symptoms
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms REPLENISH
  • Sponsors TherapeuticsMD

    • Most Recent Events

    • 14 Feb 2022 Results (n=157) assessing bone turnover markers (BTM) in this trial, published in the Menopause.
    • 25 May 2021 According to a TherapeuticsMD media release, If FDA accepted the sNDA, the company expects that the review time under the Prescription Drug User Fee Act (PDUFA) will be within ten months of receipt by the FDA, approximately March 21, 2022.
    • 27 Apr 2020 Results (n=157) of post-hoc analysis assessing bone turnover markers in women with Vasomotor Symptoms, presented at the 69th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists.

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