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.
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
- 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