In a pooled analysis of the 52-week Phase 3 trials SKYLIGHT 1, 2 and 4, change in endometrial thickness from baseline was similar across fezolinetant and placebo treatment groups, and the rates of endometrial hyperplasia and malignancy were within FDA pre-specified limits
Kagan R, Cano A, Nappi RE, et al. Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause: Pooled Analysis of Three Randomized Phase 3 Studies. Adv Ther. 2024; Available at: https://doi.org/10.1007/s12325-024-03073-8.
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