O-032 Effect of relugolix combination therapy in women with endometriosis-associated pain who received prior first-line hormonal treatment: SPIRIT 1 and 2

Abstract Study question To assess the effect of oral relugolix combination therapy (Relugolix-CT) in subgroup women with endometriosis-associated pain who received prior first-line hormonal treatment. Summary answer Relugolix-CT significantly reduced dysmenorrhoea and non-menstrual pelvic (NMPP) through 24 weeks What is known already ESHRE recommends contraceptives or progestogens as for endometriosis; however, these treatments may not be efficacious all women. SPIRIT 1&2 were Phase 3, replicate, randomised studies (relugolix 40 mg, estradiol 1 norethisterone acetate 0.5 mg) premenopausal (aged 18–50 years) moderate-to-severe pain. In 1&2, improved dysmenorrhoea, NMPP daily functioning (measured by Endometriosis Health Profile-30 domain score) compared placebo over weeks. was well-tolerated bone mineral density showed a minimal decline (<1%) from baseline to Week 24. design, size, duration At screening, required have at least moderate menstrual during their last cycle. total, 1261 diagnosed endometriosis 1:1:1 receive once-daily weeks, delayed mg then Relugolix-CT; 12 each). candidates treatment completed washout period screening run-in period. Participants/materials, setting, methods Analyses performed using pooled data previously receiving (e.g. and/or progestogens; N = 392). Co-primary endpoints: proportion responders Responders achieving predefined, clinically meaningful reduction Numerical Rating Scale (NRS [0=no pain, 10=worst imaginable]) score no increase analgesic use. Least squares (LS) mean changes NRS scores assessed mixed-effects model. Main results role chance 121 group 134 had treatment, which combined dienogest most common medications. Data used safety assessment only are reported here. Baseline demographics clinical characteristics comparable between overall study population. this subgroup, vs 70.2% 27.6%, respectively (p < 0.0001); 60.3% 40.3%, 0.0013). group, LS decreased 7.2 (severe) 1.7 (mild) 24, significant change 0.0001). 5.6 (moderate) 2.8 Relugolix-CT, 0.0097). The analgesic-free 7.4% 3.7% placebo; increased 48.8% 18.7% Limitations, reasons caution Assessment visit done after wash-out period; therefore, symptoms experienced while entry, well previous treatments, available. Wider implications findings NMPP, placebo, Relugolix-CT. Results Trial registration number NCT03204318; NCT03204331