TABLE 1.
Demographics and baseline disease characteristics (mITT) c
| Oteseconazole (N = 160) | Fluconazole (N = 159) | |
|---|---|---|
| Age (year) | ||
| Mean (SD) | 29.9 (8.0) | 31.2 (7.5) |
| Median (min, max) | 29 (18, 70) | 31 (18, 50) |
| Ethnicity | ||
| Han | 152 (95.0) | 149 (93.7) |
| Other | 8 (5.0) | 10 (6.3) |
| Weight (kg) | ||
| Mean (SD) | 56.6 (9.2) | 55.6 (8.7) |
| Median (min, max) | 55.0 (42.0, 95.0) | 55.0 (40.0, 90.0) |
| BMI (kg/m2) | ||
| Mean (SD) | 21.4 (3.5) | 21.5 (3.2) |
| Median (min, max) | 20.8 (15.6, 37.1) | 20.8 (16.4, 32.9) |
| Composite VSS score | ||
| Mean (SD) | 8.7 (1.8) | 8.4 (1.8) |
| Median (min, max) | 8.0 (7, 14) | 8.0 (7, 14) |
| Candida species a | ||
| Candida albicans | 128 (80.0) | 121 (76.1) |
| Candida glabrata | 22 (13.8) | 27 (17.0) |
| Candida tropicalis | 5 (3.1) | 3 (1.9) |
| Candida krusei | 1 (0.6) | 2 (1.3) |
| Candida spherical | 2 (1.3) | 2 (1.3) |
| Candida parapsilosis | 1 (0.6) | 2 (1.3) |
| Kodamaea ohmeri | 0 | 1 (0.6) |
| Candida dubliniensis | 1 (0.6) | 0 |
| Saccharomyces cerevisiae | 0 | 1 (0.6) |
| Candida lusitaniae | 0 | 1 (0.6) |
| Susceptibility testing b | ||
| Sensitive | 309 (96.6) | 233 (72.8) |
| Resistant | 6 (1.9) | 32 (10.0) |
| Dose-dependently sensitive | 0 | 53 (16.6) |
| Wild strain | 2 (0.6) | 2 (0.6) |
| Unknown | 3 (0.9) | 0 |
a
Determined by mycological culture of vaginal secretion.
b
A total of 320 fungal strains were isolated from 319 subjects and 320 was set as the denominator. One subject in the fluconazole group presented with two strains (Candida parapsilosis and Kodamaea ohmeri).
c
Data are n (%) unless otherwise indicated. Abbreviations: BMI, body mass index; max, maximum; min, minimum; mITT, modified intention-to-treat; N, number of subjects in the mITT population; SD, standard deviation; VSS, vulvovaginal signs and symptoms.