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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2018

At a glance

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

    • 28 Mar 2018 Planned End Date changed from 1 Jun 2018 to 1 Nov 2018.
    • 28 Mar 2018 Planned primary completion date changed from 1 Jun 2018 to 1 Nov 2018.
    • 23 Mar 2018 According to a Mithra Pharmaceuticals media release, the minimum number of female cycles required by regulators in this pivotal Phase III study has now been successfully completed.
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