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A Single Center, Randomized,Open-label,Controlled, Three-arm Study to Evaluate the Effect of a New Combined Oral Contraceptive (COC) Containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and of Two Reference COCs Containing Either 30 mcg Ethinylestradiol (EE) and 150 mcg Levonorgestrel (LNG) or 20 mcg EE and 3 mg DRSP on Endocrine Function, Metabolic Control and Hemostasis During 6 Treatment Cycles

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A Single Center, Randomized,Open-label,Controlled, Three-arm Study to Evaluate the Effect of a New Combined Oral Contraceptive (COC) Containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and of Two Reference COCs Containing Either 30 mcg Ethinylestradiol (EE) and 150 mcg Levonorgestrel (LNG) or 20 mcg EE and 3 mg DRSP on Endocrine Function, Metabolic Control and Hemostasis During 6 Treatment Cycles

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Sep 2022

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At a glance

  • Drugs Drospirenone/estetrol (Primary) ; Drospirenone/ethinylestradiol; Ethinylestradiol/levonorgestrel
  • Indications Pregnancy
  • Focus Pharmacodynamics
  • Sponsors Estetra SPRL

    • Most Recent Events

    • 13 Sep 2022 Results assessing impact on thrombin generation of new combined oral contraceptive containing estetrol and drospirenone with ethinylestradiol associated published in the Journal of Clinical Endocrinology and Metabolism
    • 23 Mar 2021 Results assessing endocrine and metabolic profile of Drospirenone/estetrol, presented at the 103rd Annual Meeting of the Endocrine Society
    • 06 Mar 2021 Results presented at the annual meeting of the International Society for the Study of Women's Sexual Health (ISSWSH) as per the Mayne Pharma Media Release

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