PASSReviewer 1· 90% conf
The trial is a randomized, double-blind, placebo-controlled phase 3b study with adequate randomization, blinding, power analysis, and pre-specified endpoints.
Evidence
direct quote[Methods, Study design, objectives, and participants]
“Individuals aged 40-65 years with moderate-severe vasomotor symptoms associated with menopause and considered unsuitable candidates for hormone therapy were randomised 1:1 using interactive response technology to fezolinetant 45 mg or placebo once daily and stratified by smoking status (current and non-smoker (former or never)).”direct quote[Methods, Statistical analysis]
“For a pairwise comparison of the primary endpoint using a two sample t test at a two sided 5% α, we determined that 220 participants in each group would provide at least 80% power to detect a difference from placebo of –1.8, assuming a standard deviation (SD) of 5.6.”direct quote[Methods, Study design, objectives, and participants]
“The present study was a phase 3b, randomised, double blind, placebo controlled trial to assess the efficacy and safety of fezolinetant for treating moderate-severe vasomotor symptoms associated with menopause in individuals considered unsuitable for hormone therapy.”PASSReviewer 2· 95% conf
The trial is well-designed with clear randomization, blinding, power analysis, and pre-specified endpoints.
Evidence
direct quote[Methods, Study design]
“Individuals aged 40-65 years with moderate-severe vasomotor symptoms associated with menopause and considered unsuitable candidates for hormone therapy were randomised 1:1 using interactive response technology to fezolinetant 45 mg or placebo once daily and stratified by smoking status (current and non-smoker (former or never)).”direct quote[Methods, Statistical analysis]
“For a pairwise comparison of the primary endpoint using a two sample t test at a two sided 5% α, we determined that 220 participants in each group would provide at least 80% power to detect a difference from placebo of –1.8, assuming a standard deviation (SD) of 5.6.”direct quote[Methods, Study design]
“The present study was a phase 3b, randomised, double blind, placebo controlled trial”