Sequential treatment with relugolix combination therapy in women with symptomatic uterine fibroids that were inadequately managed with 52 mg levonorgestrel intrauterine system: the first report

Background: This is the first report aimed to evaluate the clinical impact and safety of sequential treatment with relugolix combination therapy (relugolix CT) in women with symptomatic uterine fibroids that were inadequately managed with 52 mg levonorgestrel intrauterine system (LNG-IUS) monotherapy. Materials and methods: The patients included four women aged 45-52 (mean: 48) years with symptomatic uterine fibroids, sometimes with coexisting adenomyosis, and bleeding persistence despite treatment with the LNG-IUS (52 mg) contraceptive for more than 6 months. The intervention included the combined use of LNG-IUS (52 mg) and relugolix CT (relugolix 40 mg + oestradiol 1 mg + norethisterone acetate 0.5 mg daily). Results: All women (100%) reported complete resolution of bleeding and improved quality of life following the initiation of relugolix CT while maintaining LNG-IUS (52 mg) in place as a contraceptive. No adverse events were observed. The mean followup was 11.2 (range 3-24) months, and satisfaction with the combined treatment was reported as 9.4/10. Conclusion: The sequential combination of the contraceptive LNG-IUS (52 mg) and relugolix CT may offer a safe, well tolerated, and effective non-surgical alternative for the management of symptomatic uterine fibroids, particularly in women who do not completely respond to a 6-month treatment with LNG-IUS (52 mg). These findings support further prospective investigation into this dual therapeutic sequential strategy for symptomatic uterine fibroids.