Five-Year Efficacy and Safety of the Liletta® Levonorgestrel Intrauterine System [13F

Abstract

INTRODUCTION: Liletta is a levonorgestrel 52 mg contraceptive intrauterine system (IUS) currently approved for contraception for up to four years based on an ongoing multicenter trial currently planned to continue for up to eight years of use. We evaluated the five-year efficacy and safety data for Liletta. METHODS: Women aged 16-45 years were enrolled; those women aged 36-45 years received the IUS for safety evaluation only. We followed 1,568 women aged 16-35 years and 146 women aged 36-45 years after successful IUS placement. We assessed five-year pregnancy rates and safety outcomes. RESULTS: The 16-35 year old subjects included 1,011 (57.7%) nulliparous and 438 (25.1%) obese women. Among these women, nine pregnancies occurred including four in nulliparous women and one in an obese woman. One pregnancy occurred following perforation and one following expulsion. Six (67%) pregnancies were ectopic. The Pearl Index in the first year was .15 (95% CI .02-.55). Cumulative life-table pregnancy rates through years three and five were .59 (95% CI .28-1.25) and .92 (95% CI .46-1.82), respectively. Perforation following IUS placement occurred in two (0.1%) women; both were diagnosed within the first year. Expulsion occurred in 63 (3.7%) participants, most (50 [80.6%]) during the first year of use. Pelvic infection was diagnosed in 11 (.6%) women. Only 39 (2.3%) women discontinued due to bleeding complaints, primarily (n=29 [74.3%]) in the first year. CONCLUSION: Liletta is highly effective and has an excellent safety profile over five years of use; most expulsions and discontinuation for bleeding occur during the first year of use.