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A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone

Trial Profile

A Multicenter, Open-label, Single-Arm Study to Evaluate the Contraceptive Efficacy and Safety of a Combined Oral Contraceptive Containing 15 mg Estetrol and 3 mg Drospirenone

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2023

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At a glance

  • Drugs Drospirenone/estetrol (Primary)
  • Indications Pregnancy
  • Focus Registrational; Therapeutic Use
  • Acronyms E4 FREEDOM
  • Sponsors Estetra SPRL
  • Most Recent Events

    • 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.
    • 15 Oct 2022 Results of a pooled analysis assessing tolerability and safety of estetrol/drospirenone combined oral contraceptive from two clinical trials: NCT02817841 and NCT02817828 published in the Contraception
    • 21 Sep 2022 According to a Lotus Pharmaceuticals media release, the Taiwan Food and Drug Administration (TFDA) and Hong Kong Drug Office, Department of Health has approved ALYSSA as oral contraceptive.
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