TABLE 2.
Participant demographic and baseline characteristics (MITT population)
| Characteristic | TX-004HR 4 μg (n = 186) | TX-004HR 10 μg (n = 188) | TX-004HR 25 μg (n = 186) | Placebo (n = 187) |
| Participants | ||||
| Age, yrs | 59.8 ± 6.0 | 58.6 ± 6.3 | 58.8 ± 6.2 | 59.4 ± 6.0 |
| Race, n (%) | ||||
| White | 162 (87.1) | 165 (87.8) | 161 (86.6) | 160 (85.6) |
| Black or African American | 20 (10.8) | 21 (11.2) | 24 (12.9) | 21 (11.2) |
| Asian | 3 (1.6) | 2 (1.1) | 1 (0.5) | 1 (0.5) |
| BMI, kg/m2 | 26.6 ± 4.9 | 26.8 ± 4.7 | 26.8 ± 4.8 | 26.6 ± 4.6 |
| Natural menopause, n (%) | 111 (59.7) | 114 (60.6) | 118 (63.4) | 124 (66.3) |
| Hysterectomized, n (%) | 87 (46.8) | 86 (45.7) | 85 (45.7) | 73 (39.0) |
| Years since menopause, yrs | 14.2 ± 8.9 | 14.3 ± 9.4 | 13.8 ± 9.4 | 13.9 ± 9.4 |
| Baseline characteristics | ||||
| Superficial cells, % | 1.3 ± 1.2 | 1.2 ± 1.2 | 1.3 ± 1.2 | 1.3 ± 1.3 |
| Parabasal cells, % | 52.3 ± 39.2 | 51.3 ± 38.0 | 53.5 ± 38.3 | 52.0 ± 39.2 |
| Vaginal pH | 6.3 ± 0.9 | 6.3 ± 0.8 | 6.3 ± 0.9 | 6.3 ± 1.0 |
| Dyspareunia, severity score | 2.7 ± 0.5 | 2.6 ± 0.5 | 2.7 ± 0.4 | 2.7 ± 0.5 |
| Dryness, severity score | 2.3 ± 0.7 | 2.4 ± 0.7 | 2.4 ± 0.7 | 2.4 ± 0.7 |
| Vaginal color | ||||
| Mean ± SD | 1.8 ± 0.6 | 1.8 ± 0.6 | 1.8 ± 0.6 | 1.8 ± 0.6 |
| Moderate-to-severe, n (%) | 139 (74.7) | 133 (70.7) | 131 (70.4) | 130 (69.5) |
| Vaginal epithelial integrity | ||||
| Mean ± SD | 1.6 ± 0.9 | 1.4 ± 0.9 | 1.5 ± 0.8 | 1.5 ± 0.8 |
| Moderate-to-severe, % | 101 (54.3) | 98 (52.1) | 93 (50.0) | 95 (50.8) |
| Vaginal epithelial surface thickness | ||||
| Mean ± SD | 1.9 ± 0.7 | 1.9 ± 0.7 | 1.9 ± 0.6 | 1.9 ± 0.6 |
| Moderate-to-severe, % | 146 (78.5) | 136 (72.3) | 144 (77.4) | 145 (77.5) |
| Vaginal secretions | ||||
| Mean ± SD | 1.7 ± 0.7 | 1.7 ± 0.7 | 1.7 ± 0.6 | 1.8 ± 0.6 |
| Moderate-to-severe, % | 128 (68.8) | 126 (67.0) | 125 (67.2) | 137 (73.3) |
Data are represented as mean ± SD unless stated otherwise.
MITT, modified intent-to-treat.