Sexual function in perimenopausal women treated with relugolix and add back therapy for uterine fibroids: an observational study

Objectives: Uterine leiomyomas may cause disorders such as bleeding and bulky symptoms impacting on quality of life; a recent therapeutic option is relugolix, a GnRH antagonist effective in controlling bleeding and reducing the size of fibroids, administered in combination with low-dose oestrogens and progestins (add back therapy, ABT) to prevent related side effects of drug-induced menopause. Sexual function can be affected by leiomyomas, while the effect of such treatments on this issue is uncertain, considering both potential benefits from fibroid size reduction and concerns about hypoestrogenism. The aim of the present study is to evaluate the effect of relugolix-ABT on sexual function in premenopausal women treated for symptomatic uterine leiomyomas. Methods: The study included 21 premenopausal women affected by uterine fibroids with moderate-to-severe symptoms, treated with oral combination of relugolix 40 mg with ABT (oestradiol hemihydrate 1 mg + norethisterone acetate 0.5 mg). Sexual function was evaluated using the FSFI (Female Sexual Function Index) questionnaire at baseline and after 6 months of treatment; primary endpoint was the change in FSFI, along with secondary outcomes relating to treatment efficacy. Results: At 6 months no statistically significant changes in total FSFI scores were detected (23.0 +/- 8.0 vs 23.1 +/- 7.1, p 0.70); treatment resulted in a significant reduction in total volume (p 0.019) and mean diameter of fibroids (p 0.011) and in 87.5% of cases bleeding was effectively controlled. Conclusion: Treatment with relugolix-ABT was not associated with statistically significant changes in sexual function, with a good tolerability profile, while effectively reducing the fibroid size and controlling bleeding in most cases.