An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE

Trial Profile

An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Sep 2017

At a glance

  • Drugs Ethinylestradiol/levonorgestrel (Primary) ; Ethinylestradiol/levonorgestrel (Primary)
  • Indications Pregnancy
  • Focus Registrational; Therapeutic Use
  • Acronyms NEW CHOICE II
  • Sponsors Agile Therapeutics
  • Most Recent Events

    • 27 Jul 2017 According to an Agile Therapeutics media release, the US FDA has accepted for review the Company's NDA resubmission for Twirla (AG200-15). The NDA resubmission was submitted on June 26, 2017. The FDA stated that it considers the resubmission to be a complete response to the CRL and established December 26, 2017 as the Prescription Drug User Fee Act (PDUFA) goal date.
    • 06 May 2013 Results were presented at the American College of Obstetricians and Gynecologists' (ACOG) 61st Annual Clinical Meeting, according to an Agile Therapeutics media release.
    • 22 Aug 2011 Actual end date (Jun 2011) added as reported by ClinicalTrials.gov.
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