The use of fezolinetant in women over 65 years of age is not contraindicated, although its use has not yet been studied in this age group
Figure 1. Change in VMS frequency from baseline to Week 12 by baseline age in the full analysis set (all randomized participants assessed according to the randomization at first dose).1
The number of participants with baseline data are shown.
P values were calculated without multiplicity adjustment.
Total number of participants – Fezolinetant 30 mg: n = 339, Fezolinetant 45 mg: n = 341, Placebo: n = 342.
Adapted from: Santoro NF, Menopause, 2024.
Figure 2. Change in VMS severity from baseline to Week 12 by baseline age in the full analysis set (all randomized participants assessed according to the randomization at first dose).1
The number of participants with baseline data are shown.
P values were calculated without multiplicity adjustment.
Baseline results include moderate and severe incidences while post-baseline results include mild, moderate, and severe incidences.
Total number of participants – Fezolinetant 30 mg: n = 339, Fezolinetant 45 mg: n = 341, Placebo: n = 342.
Adapted from: Santoro NF, Menopause, 2024.
Santoro N, Nappi R, Neal-Perry G, et al. Fezolinetant treatment of moderate-to-severe vasomotor symptoms due to menopause: Effect of intrinsic and extrinsic factors in two phase 3 studies (SKYLIGHT 1 and 2). Menopause. 2024;31(4):247-257. Available at: https://doi.org/10.1097/gme.0000000000002340.
Neal-Perry G, Cano A, Lederman S, et al. Safety of Fezolinetant for Vasomotor Symptoms Associated With Menopause: A Randomized Controlled Trial. Obstet Gynecol. 2023;141(4):737-747. Available at: https://doi.org/10.1097/aog.0000000000005114.
Data on file.
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