Table 2.
Key participant demographics and baseline characteristics
| 12-Week double-blind period (SAF)a | ||||
|---|---|---|---|---|
| Parameter | Placebo (n = 167) | Fezolinetant 30 mg (n = 166) | Fezolinetant 45 mg (n = 167) | Total (N = 500) |
| Ethnicity, No. (%) | ||||
| Not Hispanic or Latina | 134 (80.7) | 132 (79.5) | 126 (75.4) | 392 (78.6) |
| Hispanic or Latina | 32 (19.3) | 34 (20.5) | 41 (24.6) | 107 (21.4) |
| Missing | 1 | 0 | 0 | 1 |
| Race, No. (%) | ||||
| American Indian or Alaska Native | 0 | 0 | 1 (0.6) | 1 (0.2) |
| Black or African American | 31 (18.6) | 35 (21.1) | 33 (19.8) | 99 (19.8) |
| Korean | 1 (0.6) | 0 | 0 | 1 (0.2) |
| > 1 race | 1 (0.6) | 0 | 1 (0.6) | 2 (0.4) |
| White | 134 (80.2) | 131 (78.9) | 132 (79.0) | 397 (79.4) |
| Age, mean (SD), y | 54.7 (4.6) | 53.9 (4.9) | 54.3 (5.4) | 54.3 (5.0) |
| Weight, mean (range), kg | 74.57 (46.2–125.0) | 75.33 (48.0–108.4) | 74.62 (45.0–107.4) | 74.84 (45.0–125.0) |
| BMI, mean (range), kg/m2 | 28.16 (18.6–38.0) | 27.94 (18.1–37.6) | 27.91 (18.0–37.5) | 28.00 (18.0–38.0) |
| Current smoker, No. (%) | 35 (21.0) | 34 (20.5) | 34 (20.4) | 103 (20.6) |
| Time since onset of VMS, mean (range), mo | 81.9 (3–364) | 76.2 (3–370) | 81.7 (2–396) | 80.0 (2–396) |
| Amenorrhea, No. (%) | ||||
| No | 8 (4.8) | 3 (1.8) | 5 (3.0) | 16 (3.2) |
| Yes | 159 (95.2) | 163 (98.2) | 162 (97.0) | 484 (96.8) |
| Hysterectomy, No. (%) | ||||
| No | 116 (69.5) | 113 (68.1) | 111 (66.5) | 340 (68.0) |
| Yes | 51 (30.5) | 53 (31.9) | 56 (33.5) | 160 (32.0) |
| Oophorectomy, No. (%) | ||||
| No | 130 (77.8) | 132 (79.5) | 129 (77.2) | 391 (78.2) |
| Yes | 37 (22.2) | 34 (20.5) | 38 (22.8) | 109 (21.8) |
| Start of fezolinetant treatment (SAF-fezolinetant exposure)b | |||||
|---|---|---|---|---|---|
| Parameter | Fezolinetant 30 mg (n = 166) | Fezolinetant 45 mg (n = 167) | Placebo/Fezolinetant 30 mg (n = 76) | Placebo/Fezolinetant 45 mg (n = 75) | Total (n = 484) |
| Ethnicity, No. (%) | |||||
| Not Hispanic or Latina | 132 (79.5) | 126 (75.4) | 62 (81.6) | 58 (78.4) | 378 (78.3) |
| Hispanic or Latina | 34 (20.5) | 41 (24.6) | 14 (18.4) | 16 (21.6) | 105 (21.7) |
| Missing | 0 | 0 | 0 | 1 | 1 |
| Race, No. (%) | |||||
| American Indian or Alaska Native | 0 | 1 (0.6) | 0 | 0 | 1 (0.2) |
| Black/African American | 35 (21.1) | 33 (19.8) | 11 (14.5) | 18 (24.0) | 97 (20.0) |
| Korean | 0 | 0 | 1 (1.3) | 0 | 1 (0.2) |
| > 1 race | 0 | 1 (0.6) | 1 (1.3) | 0 | 2 (0.4) |
| White | 131 (78.9) | 132 (79.0) | 63 (82.9) | 57 (76.0) | 383 (79.1) |
| Age, mean (SD), y | 53.9 (4.9) | 54.3 (5.4) | 54.3 (4.2) | 55.3 (4.9) | 54.3 (5.0) |
| Weight, mean (range), kg | 75.33 (48.0–108.4) | 74.62 (45.0–107.4) | 75.84 (48.8–112.0) | 74.0 (46.2–125.0) | 74.96 (45.0–125.0) |
| BMI, mean (range), kg/m2 | 27.94 (18.1–37.6) | 27.91 (18.0–37.5) | 28.70 (20.0–38.0) | 27.87 (18.6–37.9) | 28.04 (18.0–38.0) |
| Current smoker, No. (%) | 34 (20.5) | 34 (20.4) | 15 (19.7) | 14 (18.7) | 97 (20.0) |
| Time since onset of VMS, mean (range), mo | 76.2 (3–370) | 81.7 (2–396) | 73.4 (5–308) | 98.2 (3–364) | 81.1 (2–396) |
| Amenorrhea, No. (%) | |||||
| No | 3 (1.8) | 5 (3.0) | 5 (6.6) | 3 (4.0) | 16 (3.3) |
| Yes | 163 (98.2) | 162 (97.0) | 71 (93.4) | 72 (96.0) | 468 (96.7) |
| Hysterectomy, No. (%) | |||||
| No | 113 (68.1) | 111 (66.5) | 51 (67.1) | 52 (69.3) | 327 (67.6) |
| Yes | 53 (31.9) | 56 (33.5) | 25 (32.9) | 23 (30.7) | 157 (32.4) |
| Oophorectomy, No. (%) | |||||
| No | 132 (79.5) | 129 (77.2) | 57 (75.0) | 59 (78.7) | 377 (77.9) |
| Yes | 34 (20.5) | 38 (22.8) | 19 (25.0) | 16 (21.3) | 107 (22.1) |
Data shown in terms of No. (%), unless otherwise stated.
Abbreviations: BMI, body mass index; SAF, safety analysis set; VMS, vasomotor symptoms.
For the double-blind period, data were collected from the first dose of study drug until week 12.
For the extension period, data were collected from the first dose of study drug until week 52 for the fezolinetant groups and from week 13 to week 52 for the placebo/fezolinetant groups.