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

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Trial Profile

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

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 16 Aug 2024

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At a glance

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

Most Recent Events

  • 22 Jul 2024 According to ClinicalTrials.gov record , the trial was terminated as the data cutoff date of 05 April 2021 was chosen as it coincides with all subjects completing through Year 8 of use (intended duration of use for the product).
  • 22 Jul 2024 Status changed from completed to discontinued.
  • 10 Jul 2023 According to a Medicines360 media release, the U.S. Food and Drug Administration (FDA) has approved supplemental New Drug Application (sNDA) for LILETTA (levonorgestrel-releasing intrauterine system) 52 mg for treatment of Heavy Menstrual Bleeding (HMB) for up to five years in patients who choose intrauterine contraception as their method of contraception, based on data from this trial.

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