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

Trial Profile

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

Completed
Phase of Trial: Phase II

Latest Information Update: 28 Mar 2018

At a glance

  • Drugs Drospirenone/estetrol (Primary) ; Drospirenone/ethinylestradiol; Ethinylestradiol/levonorgestrel
  • Indications Pregnancy
  • Focus Pharmacodynamics
  • Sponsors Estetra S.A.
  • Most Recent Events

    • 28 Mar 2018 According to a Mithra Pharmaceuticals media release, the company has filed an additional patent application in Europe based on the data generated in the sub-study of this trial.
    • 08 Feb 2018 According to a Mithra Pharmaceuticals media release, the company will present the hemostasis data at the ESC- Congress of the European Society of Contraception & Reproductive Health (Budapest, May 9-12, 2018)
    • 08 Feb 2018 According to a Mithra Pharmaceuticals media release, the company announced hemostasis results from this trial and will present the data at the ISGE- Gynaecological Endocrinology Conference (March 7-10, 2018)
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