Results from a phase 3 trial assessing the intrauterine system (IUS), Liletta (levonorgestrel 52mg; Medicines360), found that it had >99% efficacy in preventing pregnancy for up to 5 years. The data, published in Obstetrics & Gynecology, supports the recent indication approved by the Food and Drug Administration (FDA) in October 2018.
The phase 3 ACCESS IUS (A Comprehensive Contraceptive Efficacy & Safety Study of an IUS) study follows 1751 women who received Liletta for an intended time of 5 years, however, at the time of the data evaluation only 495 participants finished 5 years while 176 had entered their 7th year of IUS use. Most of the participants (n=1600) were aged between 16 and 35 years; the remaining were aged between 36 and 45 years.
The primary outcome was pregnancy rate (Pearl Index) in females aged 16 to 35 years at enrollment through the 5-year period. Results showed that the Pearl Indices for years 1 and 5 were 0.15 (95% CI 0.02–0.55) and 0.20 (95% CI 0.01–1.13) pregnancies per 100 women-years, respectively. The cumulative life-table pregnancy rate was 0.92% (0.46–1.82%) through 5 years. In total, 9 pregnancies occurred, 6 of which were ectopic.
The study also evaluated rates of amenorrhea for Liletta up to 5 years of continued use. At the end of 5 years, 42% of study patients had reported amenorrhea and 90% reported only amenorrhea, spotting, or light bleeding. Thirty-nine (2.2%) participants discontinued due to bleeding symptoms.
“As more women in the US request long-acting reversible contraception, especially hormonal IUSs, demonstrating a 5-year duration of use for Liletta is important for both women’s and public health,” said Mitchell D. Creinin, MD, Professor of Obstetrics and Gynecology at the University of California, Davis and an author of the manuscript.
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