6/28/23, 10:01 PM ETESRTA Pathway Feedback Search Clinical Topics Home Studies ETESRTA ETESRTA Disease Adenomyosis Trial question What is the effect of mifepristone in patients with adenomyosis with pain symptoms? Study design Multi-center Double blinded RCT Population 126 female patients Inclusion criteria: adult female patients with adenomyosis and dysmenorrhea Key exclusion criteria: history of undiagnosed vaginal bleeding outside reference ranges; endometrial malignant tumors; uterine fibroids or endometriosis Interventions N=61 mifepristone (at an oral dose of 10 mg/day for 12 weeks) N=65 placebo (matching placebo once daily for 12 weeks) Primary outcome Reduction in adenomyosis-associated dysmenorrhea intensity, evaluated by visual analog scale at 12 weeks 6.6 6.63 5.0 3.3 1.7 Significant increase 0.95 0.0 https://web.pathway.md/studies/recUb6iwbnm3HP58S 1/2 6/28/23, 10:01 PM ETESRTA Pathway 0.0 Mifepristone Placebo Significant increase in reduction in adenomyosis-associated dysmenorrhea intensity, evaluated by visual analog scale at 12 weeks (6.63 vs. 0.95; AD 5.68, 95% CI 4.99 to 6.37) Secondary outcomes Significant increase in complete remission rate for heavy menstrual bleeding (90% vs. 5.41%; AD 84.6%, 95% CI 72.8 to 96.4) Significant increase in total effective rate for heavy menstrual bleeding (95% vs. 37.84%; AD 57.2%, 95% CI 40.1 to 74.2) Significant increase in complete remission rate for anemia (77.78% vs. 22.85%; AD 53.5%, 95% CI 33.6 to 73.5) Safety outcomes No significant difference in adverse events. Conclusion In adult female patients with adenomyosis and dysmenorrhea, mifepristone was superior to placebo with respect to reduction in adenomyosis-associated dysmenorrhea intensity, evaluated by visual analog scale at 12 weeks. Reference Xuan Che, Jianzhang Wang, Wenting Sun et al. Effect of Mifepristone vs Placebo for Treatment of Adenomyosis With Pain Symptoms: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317860. Open reference URL https://web.pathway.md/studies/recUb6iwbnm3HP58S 2/2