Levonorgestrel 52-mg Intrauterine Device Efficacy and Safety After More Than 8 Years of Use

The levonorgestrel 52-mg intrauterine device (IUD) is approved for contraception for 8 years. We evaluated outcomes for 339 phase 3 study participants aged 16-35 years at enrollment who used the IUD for more than 8 years. At study closure, 83 and 77 participants reached 9 and 10 years, respectively. No pregnancies occurred during years 9 and 10. Expulsion occurred in one (0.3%) participant, a partial expulsion during year 10. No perforations, pelvic infections, or IUD-related serious adverse events were noted. Absence of bleeding or spotting was reported by 33 (39.8%) and 28 (36.4%) participants at years 9 and 10, respectively. The levonorgestrel 52-mg IUD demonstrates continued efficacy and safety in a small population of users during years 9 and 10 of use.FUNDING SOURCE:Medicines360. The Sponsor, Medicines360, designed the study and oversaw its conduct, including funding the trial and providing all study product free of charge to participants.