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A crossover, randomized, study comparative wear study between Twirla and Xulane in healthy women

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Trial Profile

A crossover, randomized, study comparative wear study between Twirla and Xulane in healthy women

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Feb 2020

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At a glance

  • Drugs Ethinylestradiol/levonorgestrel (Primary) ; Ethinylestradiol/norelgestromin
  • Indications Pregnancy
  • Focus Registrational; Therapeutic Use
  • Sponsors Agile Therapeutics

Most Recent Events

  • 14 Feb 2020 According to an Agile Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved Twirla (levonorgestrel and ethinyl estradiol) transdermal system.
  • 02 Jan 2020 According to an Agile Therapeutics media release, the FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of February 16, 2020.
  • 30 Oct 2019 According to an Agile Therapeutics media release, the company announced a positive outcome from of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of the U.S. Food and Drug Administration (FDA) from the discussion of New Drug Application (NDA) for the comapny's lead product candidate, Twirla.

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