Discontinuation rates for bleeding events among women using the Liletta® levonorgestrel-releasing intrauterine system for up to 3 years

Abstract

Objectives: We examined discontinuation rates for bleeding events during the first 3 years of use of the Liletta® levonorgestrel 52-mg intrauterine system. Methods: Eligible women aged 16–45 were enrolled in a multicenter trial designed to evaluate the efficacy and safety of Liletta for up to 7 years (n=1751). Subjects with successful placement (n=1714) were followed with regular study visits and phone calls. Reasons for early study discontinuation were captured and examined at 3-month intervals for bleeding-related complaints. Bleeding-related events included amenorrhea, abnormal uterine bleeding and increased, irregular or heavy bleeding. Results: Over 3 years, 35 women (2%) discontinued for bleeding-related complaints, including 17 during year 1, 13 in year 2 and 5 in year 3. Discontinuation for bleeding complaints comprised only 3.9% of the total number of discontinuations. Most bleeding-related discontinuations were for heavy (n=10) or irregular bleeding (n=12). Only one woman discontinued for a complaint of amenorrhea, requesting intrauterine system removal after 15 months of use. Age at enrollment did not result in appreciably different rates of discontinuation for a bleeding complaint (16–35 years, 1.9%; 36–45 years 3.3%; p=.23). Women were most likely to discontinue intrauterine system use for bleeding-related reasons between months 9 and 15. Conclusions: Very few women discontinue Liletta for bleeding irregularities. The finding that only one woman discontinued Liletta for amenorrhea supports the idea that suppression of menstruation is an acceptable effect of hormonal intrauterine contraception.