Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT
Authors' conclusion
Daily fezolinetant 30 and 45 mg were efficacious and well tolerated for treating moderate to severe VMS associated with menopause.
Study context
- Population
- Women aged 40 to 65 years with minimum average 7 moderate to severe vasomotor symptoms (VMS)/day associated with menopause
- Comparison
- Fezolinetant 30 mg or 45 mg once daily vs placebo
- Primary endpoint
- Coprimary: mean daily change from baseline in VMS frequency and severity
- Follow-up
- W4 and W12
Methodological detailsdouble-blind, placebo-controlled, phase 3, 40-week active treatment extension, Completers were rerandomized to fezolinetant 30/45 mg for 40 additional weeks
- Double-blind
- Placebo-controlled
- Phase 3
- 40-week active treatment extension
- Completers were rerandomized to fezolinetant 30/45 mg for 40 additional weeks
Primary result
As reported in the abstract
- Fezolinetant 30 mg · SE 0.46
- LS mean reduction vs placebo (VMS frequency, W4) −1.82; P < 0.001
- Fezolinetant 45 mg · SE 0.46
- LS mean reduction vs placebo (VMS frequency, W4) −2.55; P < 0.001
- Fezolinetant 30 mg · SE 0.55
- LS mean reduction vs placebo (VMS frequency, W12) −1.86; P < 0.001
- Fezolinetant 45 mg · SE 0.55
- LS mean reduction vs placebo (VMS frequency, W12) −2.53; P < 0.001
Further findings
VMS frequency and severity over time · W1 through W52
- Improvement in VMS frequency and severity observed by W1 and maintained through W52
Safety
Serious treatment-emergent adverse events
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. Published 3 February 2023. doi:10.
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