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A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety, Compliance and Pharmacokinetics associated with the use of a Combined Oral Contraceptive Containing 15 mg Estetrol monohydrate and 3 mg Drospirenone in Post-menarchal Female Adolescents for 6 cycles

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Trial Profile

A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety, Compliance and Pharmacokinetics associated with the use of a Combined Oral Contraceptive Containing 15 mg Estetrol monohydrate and 3 mg Drospirenone in Post-menarchal Female Adolescents for 6 cycles

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Mar 2024

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At a glance

  • Drugs Drospirenone/estetrol (Primary)
  • Indications Pregnancy
  • Focus Adverse reactions; Registrational
  • Sponsors Estetra SPRL

    • Most Recent Events

    • 20 Dec 2023 Status changed from active, no longer recruiting to completed, according to a Mithra Pharmaceuticals media release.
    • 20 Dec 2023 According to a Mithra Pharmaceuticals media release, last patient last visit has been completed with data expected in Q2 2024.
    • 15 Dec 2023 This study has been completed in Poland, according to European Clinical Trials Database record.

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