Table 5.
Change from baseline in MENQOL total scorea during the 12-week double-blind period (FAS)
| Analysis visit | Statistics | Placebo (n = 167) | Fezolinetant 30 mg (n = 166) | Fezolinetant 45 mg (n = 167) |
|---|---|---|---|---|
| Baseline | No. | 165 | 165 | 167 |
| Mean (SD) | 4.40 (1.35) | 4.49 (1.34) | 4.31 (1.31) | |
| Week 4 | No. | 151b | 155c | 158 |
| Mean (SD) | 3.62 (1.39) | 3.30 (1.42) | 3.01 (1.34) | |
| LS mean change from baseline, mean (SE) LS mean difference vs placebo (SE) |
–0.75 (0.10) — |
–1.17 (0.10) –0.42 (0.14) |
–1.34 (0.09) –0.59 (0.14) |
|
| P value vs placebod | — | .002 | <.001 | |
| Week 12 | No. | 144e | 139 | 145 |
| Mean (SD) | 3.43 (1.44) | 3.22 (1.43) | 2.92 (1.33) | |
| LS mean change from baseline, mean (SE) | −0.95 (0.10) | −1.18 (0.10) | −1.43 (0.10) | |
| LS mean difference vs placebo (SE) | — | −0.23 (0.15) | –0.47 (0.15) | |
| P value vs placebod | — | .122 | .001 |
Abbreviations: FAS, full analysis set; LS, least squares; MENQOL, Menopause-Specific Quality of Life.
Comprises all 4 domains and 29 items. A negative change indicates an improvement from baseline.
n = 150 for LS change from baseline.
n = 154 for LS change from baseline.
Mixed model repeated measurements analysis of covariance model with change from baseline as the dependent variable and treatment group, week and smoking status (current vs former/never) as factors, with baseline measurement and baseline weight as covariates, as well as an interaction of treatment by week and an interaction of baseline measurement by week.
n = 142 for LS change from baseline.