A Single-arm, Open-label, Multicenter Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal Contraceptive Delivery System (TCDS)

Trial Profile

A Single-arm, Open-label, Multicenter Phase 3 Study of the Contraceptive Efficacy, Safety and Tolerability of the AG200-15 Transdermal Contraceptive Delivery System (TCDS)

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Jul 2017

At a glance

  • Drugs Ethinylestradiol/levonorgestrel (Primary)
  • Indications Pregnancy
  • Focus Registrational; Therapeutic Use
  • Acronyms SECURE
  • 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.
    • 27 Jun 2017 According to an Agile Therapeutics media release, the company has resubmitted the NDA for Twirla to the U.S. Food and Drug Administration (FDA) in response to a February 2013 Complete Response Letter (CRL) from the FDA. Data from this trial supported the resubmission.
    • 09 May 2017 Results presented at the 65th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists
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