Trial Profile
A Phase 3, Multi-Center, Open-Label Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 12 Jul 2023
Price :
$35
*
At a glance
- Drugs Levonorgestrel (Primary)
- Indications Pregnancy
- Focus Registrational; Therapeutic Use
- Acronyms ACCESS IUS
- Sponsors Medicines360
- 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.
- 14 Nov 2022 According to a Medicines360 media release, based on the data from this study, the U.S. Food and Drug Administration (FDA) has approved Supplemental New Drug Application (sNDA) to extend the duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to eight years.
- 12 May 2022 Results evaluating the efficacy and safety of levonorgestrel 52 mg IUS during years 7 and 8 of use published in the American Journal of Obstetrics and Gynecology