Six-year data from phase III trial of Liletta shows cumulative pregnancy rates

Medicines360 presented new six-year data from the ongoing multi-center U.S.-based pivotal clinical trial investigating its intrauterine system (IUS), Liletta (levonorgestrel-releasing intrauterine system) 52 mg as contraception. Investigators shared six-year pregnancy rates (by Pearl Index and life-table analysis) and safety outcomes from the ongoing ACCESS IUS (A Comprehensive Contraceptive Efficacy and Safety Study of an IUS) trial, the largest ongoing Phase III clinical trial of an IUS in the United States. The Pearl Index in the first year was 0.15 among women who were 16 to 35 years old when they enrolled in the study. At six years, the cumulative life-table pregnancy rate was 0.87.

Liletta is currently approved for up to five years for the prevention of pregnancy. The U.S. Food and Drug Administration (FDA) is currently reviewing an application requesting approval of Liletta for up to six years of use based on data from ACCESS IUS.

Two perforations following IUS placement were diagnosed within the first year, and no additional perforations have been reported in the trial to date. Expulsion occurred in 68 participants (4.0 percent). Most expulsions (73.5 percent) were diagnosed during the first year, with two diagnosed in year six. Pelvic infection was diagnosed in 15 women (0.9 percent), with most occurring (73.3 percent) after six or more months of use. Forty women (2.3 percent) discontinued due to bleeding complaints. Three quarters of these discontinuations (75.0 percent) occurred in the first two years. Data were presented at the American College of Obstetricians and Gynecologists (ACOG) 2019 Annual Clinical and Scientific Meeting.