Patient-reported outcome data from a randomized phase II study (STARLIGHT) of fezolinetant in women in Japan with vasomotor symptoms associated with menopause

OBJECTIVE: This study aimed to report results of exploratory patient-reported outcomes (PROs) from the STARLIGHT study. METHOD: Perimenopausal/postmenopausal women aged ≥40 to ≤65 years from 36 centers in Japan seeking treatment/relief for vasomotor symptoms (VMS) associated with menopause were randomized 1:1:1, stratified by menopausal status, to receive fezolinetant 15 or 30 mg or placebo orally once daily for 12 weeks. The Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b (PROMIS SD-SF 8b) total score, Menopause-Specific Quality of Life (MENQOL) total and domain scores, and Patient Global Impression of Change in Vasomotor Symptoms (PGI-C VMS) assessed the effect of fezolinetant on health-related quality of life (HRQoL). RESULTS: = 47). Improvements from baseline in the PROMIS SD-SF 8b total score and MENQOL total score were observed in the fezolinetant and placebo groups at weeks 4, 8 and 12. A higher proportion of participants in the fezolinetant 15 mg and fezolinetant 30 mg groups versus placebo reported improvement from baseline in the PGI-C VMS at weeks 4, 8 and 12. CONCLUSION: Fezolinetant was associated with improvements in PROs (PROMIS SD-SF-8b, MENQOL and PGI-C VMS); however, these analyses were exploratory and not powered for confirmatory hypothesis testing.