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A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptive vaginal ring delivering a daily dose of 150 Ug of Nestorone [elcometrine] and 15 Ug of ethinyl estradiol.

Trial Profile

A multicenter, open-label study on the efficacy, cycle control and safety of a contraceptive vaginal ring delivering a daily dose of 150 Ug of Nestorone [elcometrine] and 15 Ug of ethinyl estradiol.

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2018

At a glance

  • Drugs Estradiol/elcometrine (Primary)
  • Indications Pregnancy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Most Recent Events

    • 10 Aug 2018 According to a Food and Drug Administration media release, Based on the results of two pivotal studies (14506 and 22366 ), the U.S. Food and Drug Administration (FDA) has approved Annovera, which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.
    • 31 Jul 2018 According to a TherapeuticsMD, New Drug Application (NDA) for the one-year vaginal contraceptive system is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date for the completion of the FDA's review of the NDA of August 17, 2018
    • 01 Nov 2017 Results assessing acceptability and adherence to use of the Nestorone /Ethinylestradiol presented at the American Society for Reproductive Medicine Scientific Congress 2017
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