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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 May 2019

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At a glance

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

    • 24 Oct 2018 According to the Agile Therapeutics media release, data from this study were presented at the North American Forum on Family Planning (NAFFP). The data is also published in the October 2018 issue of Contraception.
    • 10 Oct 2018 Results assessing the safety of the AG200-15 patch in current and naive users of hormonal contraception, presented at the American Society for Reproductive Medicine Scientific Congress 2018
    • 24 Jul 2018 According to the Agile Therapeutics media release, Office Director of the FDA's Office of Drug Evaluation III (ODEIII denied Agile's appeal of the December 2017 Complete Response Letter (CRL) with respect to a New Drug Application (NDA) for ethinylestradiol/levonorgestrel (Twirla). Company intends to appeal the ODEIII decision to the Office of New Drugs.
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