Table 2.
Effect of fezolinetant on sex hormones (primary and secondary end points), intent-to-treat population
| Hormone | Treatment | Mean (SD) level at baseline | Mean (SD) level at week 12 | Adjusted Mean (SE) change from baseline to week 12a | P vs placebo |
|---|---|---|---|---|---|
| Total testosterone, nmol/L | Placebo | 2.01 (0.80) | 1.92 (0.78) | −0.05 (0.10) | — |
| Fezolinetant 60 mg | 1.65 (0.66) | 1.38 (0.59) | −0.39 (0.12) | .04 | |
| Fezolinetant 180 mg | 2.16 (1.01) | 1.39 (0.60) | −0.80 (0.13) | < .001 | |
| LH, IU/L | Placebo | 14.43 (6.51) | 12.51 (6.62) | −3.16 (1.04) | — |
| Fezolinetant 60 mg | 17.64 (16.83) | 7.84 (4.31) | −8.21 (1.18) | .002 | |
| Fezolinetant 180 mg | 14.43 (8.60) | 5.72 (4.47) | −10.17 (1.28) | < .001 | |
| FSH, IU/L | Placebo | 5.95 (1.86) | 5.53 (1.68) | −0.57 (0.26) | — |
| Fezolinetant 60 mg | 6.61 (4.41) | 5.29 (1.40) | −0.92 (0.30) | .38 | |
| Fezolinetant 180 mg | 5.67 (2.35) | 4.65 (1.14) | −1.46 (0.32) | .03 | |
| LH-to-FSH ratio | Placebo | 2.60 (1.32) | 2.33 (1.10) | −0.31 (0.16) | — |
| Fezolinetant 60 mg | 2.67 (1.62) | 1.49 (0.77) | −1.24 (0.18) | < .001 | |
| Fezolinetant 180 mg | 2.67 (1.30) | 1.16 (0.73) | −1.45 (0.19) | < .001 | |
| P4, ng/mL | Placebo | 1.31 (3.19) | 2.12 (5.60) | 0.42 (0.73) | — |
| Fezolinetant 60 mg | 2.56 (4.03) | 1.00 (1.74) | −0.77 (0.83) | .29 | |
| Fezolinetant 180 mg | 0.83 (1.10) | 0.34 (0.20) | −1.28 (0.91) | .15 | |
| E2, pmol/L | Placebo | 239.26 (203.37) | 357.31 (632.70) | 81.98 (82.35) | — |
| Fezolinetant 60 mg | 366.52 (256.01) | 255.50 (216.51) | −32.64 (93.94) | .36 | |
| Fezolinetant 180 mg | 233.48 (137.33) | 140.59 (40.38) | −135.5 (102.75) | .10 |
Abbreviations: ANCOVA, analysis of covariance; E2, estradiol; FSH, follicle-stimulating hormone; LH, luteinizing hormone; P4, progesterone.
a Least squares mean change from ANCOVA model using treatment group as a fixed factor and baseline value as a covariate.