To evaluate efficacy, safety, and bleeding with levonorgestrel 52 mg intrauterine
system (IUS) use from more than eight years through 10 years.
Eligible people aged 16–45 received a levonorgestrel 52 mg IUS (Liletta®) in a multicenter
trial evaluating efficacy and safety. After IUS placement, we followed 1,568 participants
aged 16–35 for up to 10 years and 146 participants aged 36–45 for up to eight years.
The study closed after achieving a full eight-year dataset. We evaluated pregnancy
rates, safety, and bleeding during years 9 and 10 of use. We defined absence of bleeding
as no spotting or bleeding for the preceding 90 days.
Three-hundred thirty-nine participants used the IUS for >8 years, including 166 for
>8.5 years. At study closure, 83 and 77 participants reached 9 and 10 years of use,
respectively. At 8, 9, and 10 years, 254 (75%), 64 (77%), and 44 (57%) participants,
respectively, were <40 years old. No pregnancies occurred during years 9 and 10. Expulsion
occurred in 1 (0.3%) participant, a partial expulsion at 9 years 19 days of use. No
perforations, pelvic infections, or IUS-related serious adverse events were noted
in this time period. Absence of bleeding was noted by 33 (40%) and 28 (36%) participants
at years 9 and 10, respectively. No participants discontinued for bleeding complaints
during the two-year time period.
Limited data suggest continued efficacy and safety, and a good bleeding profile, with
>8 through 10 years of continuous levonorgestrel 52 mg IUS use.