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.

Automated summary

This study evaluated the outcomes of 339 participants aged 16-35 who used the levonorgestrel 52-mg intrauterine device (IUD) for more than 8 years. No pregnancies occurred during years 9 and 10, and only one participant experienced partial expulsion during year 10. No serious adverse events were noted, and a significant number of participants reported no bleeding or spotting during years 9 and 10. The levonorgestrel 52-mg IUD demonstrated continued efficacy and safety in this small population during years 9 and 10 of use.