The following is a summary of “Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use” published in the December 2022 issue of Obstetrics & Gynecology by Creinin et al.
Less surgery will be required to offer long-term contraception if the hormonal intrauterine system is allowed to last longer. Levonorgestrel 52 mg intrauterine system’s effectiveness and safety were to be assessed by researchers throughout years 7 and 8 of usage in the study.
In phase 3, the multicenter study to assess the effectiveness and safety of using the Liletta levonorgestrel 52 mg intrauterine device for up to 10 years, a total of 1,751 nulliparous and multiparous individuals ages 16 to 45 registered. Only safety evaluations were performed on the participants, who ranged in age from 36 to 45 upon registration. Following the first year, subjects were assessed every six months for intrauterine system site confirmation and pregnancy status using urine. They evaluated the life-table analysis for cumulative pregnancy rates over 8 years of usage and the Pearl Indices in years 7 and 8. Through year 6, all individuals, ages 16 to 35 at enrolment, were included in the primary efficacy analyses; however, years 7 and 8 only included users aged ≤39 at the beginning of each use year. No of how long they had been using, all individuals had their safety results evaluated. They evaluated amenorrhea rates, which were indicated by no bleeding or spotting in the 90 days before the year’s conclusion.
Following the implantation of the intrauterine system, they followed 1,568 people aged 16 to 35 and 146 persons aged 36 to 45. The participants aged 16 to 35 comprised 986 (57.5%) nulliparous women and 433 (25.3%) obese women. Overall, 569 individuals began year 7, 478 finished year 7 (380 aged ≤39 at the start of the year), 343 finished year 8, and 77 finished all ten years of usage. Over the course of 8 years, there were 11 pregnancies, 7 (or 64%) of which were ectopic. One of the two pregnancies in year 7 (Pearl Index, 0.49; 95% CI, 0.06-1.78) occurred in a person whose implantation happened four days after the individual’s intended removal; there were no pregnancies in year 8. Without the post-removal pregnancy, the cumulative life-table pregnancy rate was 1.09 (95% CI: 0.56-2.13) and 1.32 (95% CI: 0.69-2.51) in the main efficacy population through year 8. There were just two perforations (0.1%) after the first year. 71 (4.1%) individuals have been expelled altogether, including 3 in year 7 and 2 in year 8. 16 (0.9%) individuals who used an intrauterine device had a confirmed pelvic infection, with one case each of years 7 and 8. With rates each year ranging from 0.1% to 0.5% during years 3 to 8, only 44 (2.6%) participants overall quit due to bleeding problems (4 total in years 7 and 8). The prevalence of amenorrhea was 39% in both years 7 and 8.
Over eight years of usage, the levonorgestrel 52 mg intrauterine device has proven successful and has a great prolonged safety profile. The study provided the most extensive effectiveness and safety information for long-term intrauterine usage of a levonorgestrel 52 mg contraceptive device.
Reference: ajog.org/article/S0002-9378(22)00366-0/fulltext
