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A Randomized Double-blind Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study II)

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A Randomized Double-blind Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study II)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs Estetrol (Primary)
  • Indications Vasomotor symptoms
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms E4Comfort
  • Sponsors Mithra Pharmaceuticals

    • Most Recent Events

    • 30 Nov 2023 According to a Mithra Pharmaceuticals media release, the formal NDA submission is now planned for Q4 2024 to allow for the time required to perform these additional analyses pursuant to FDA guidance.
    • 30 Nov 2023 According to a Mithra Pharmaceuticals media release, the US Food and Drug Administration (FDA) has provided feedback regarding its new drug application (NDA) marketing authorization filing in the United States. This follows an agreement in principle with the FDA for Mithra to conduct additional endometrial data analyses. The company has decided to conduct additional endometrial data analyses from its phase 3 program for the DONESTA menopause candidate-medication.
    • 28 Nov 2023 According to a Mithra Pharmaceuticals media release, data from this study will be presented at the European Society of Gynaecology Congress, which will take place from 29 November to 02 December in Amsterdam, The Netherlands.

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