A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception

Trial Profile

A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2017

At a glance

  • Drugs Levonorgestrel (Primary)
  • Indications Pregnancy
  • Focus Registrational; Therapeutic Use
  • Acronyms ACCESS IUS
  • Sponsors Medicines360
  • Most Recent Events

    • 07 Aug 2017 Based on the data from this trial, the U.S. Food and Drug Administration (FDA) has approved the company's Supplemental New Drug Application (sNDA) to extend the duration of use of LILETTA (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to four years, as reported in an Allergan media release.
    • 09 May 2017 According to a Medicines360 media release, four-year data from this study was presented at the American College of Obstetricians and Gynecologists (ACOG) annual clinical and scientific meeting.
    • 09 May 2017 Results published in a Medicines360 media release.
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