A Multicenter, Open-label Study on the Efficacy, Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of 150µg of Nestorone and 15µg of Ethinyl Estradiol (150/15 NES/EE CVR)
Phase of Trial: Phase III
Latest Information Update: 20 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.
- 22 Jun 2008 The expected completion date for this trial is now 1 Jun 2009 according to ClinicalTrials.gov.