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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

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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: 08 Aug 2024

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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

    • 01 Aug 2024 Results assessing mean changes in MDQ-t-scores from baseline to end of treatment in premenstrual (4 days before most recent flow) and menstrual (most recent flow) scores for 4 MDQ domains in starters and switchers (use of hormonal contraception in prior 3 months) and performed a shift analysis on individual symptoms within each domain were published in the European Journal of Contraception and Reproductive Health Care.
    • 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

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