Table 1.
Baseline Characteristics of Study Participants, by Randomization Group
| TOL-463 Gel | TOL-463 lnsert | |||||
|---|---|---|---|---|---|---|
| Parameter | BV (n = 28) | VVC (n = 18) | Mixed (n = 9) | BV (n = 25) |
VVC (n = 18) | Mixed (n = 8) |
| Age, y | ||||||
| Mean ± SD (min–max) |
31.5 ± 7.4 (21–46) |
30.2 ± 9.4 (19–47) |
33.3 ± 9.2 (20–47) |
29.6 ± 6.7 (19–49) |
31.4 ± 10.5 (18–48) |
34.3 ± 6.6 (24–41) |
| Ethnicity, No. (%) | ||||||
| Not Hispanic or Latino | 28 (100) | 17 (94) | 9 (100) | 21 (84) | 16 (89) | 6 (75) |
| Hispanic or Latino | 0 (0) | 1 (6) | 0 (0) | 3 (12) | 1 (6) | 1 (13) |
| Not reported or unknown | 0 (0) | 0 (0) | 0 (0) | 1 (4) | 1 (6) | 1 (13) |
| Race, No. (%) | ||||||
| White | 4 (14) | 5 (28) | 0 (0) | 2 (8) | 4 (22) | 1 (13) |
| African American | 18 (64) | 10 (56) | 8 (89) | 22 (88) | 9 (50) | 6 (75) |
| Asian | 2 (7) | 0 (0) | 0 (0) | 0 (0) | 1 (6) | 0 (0) |
| Hawaiian/Pacific Islander | 1 (4) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| American Indian/Alaska Native | 0 (0) | 1 (6) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Multiple/other | 3 (11) | 2 (11) | 1 (11) | 1 (4) | 4 (22) | 1 (13) |
| BV/VVC history, No. (%) | ||||||
| Treated for BV in past 60 d | 4 (14) | 2 (11) | 4 (44) | 8 (32) | 2 (11) | 3 (38) |
| Treated for VVC in past 60 d | 3 (11) | 5 (28) | 4 (44) | 4 (16) | 3 (17) | 2 (25) |
| ≥3 BV episodes in past 12 mo | 5 (18) | 0 (0) | 2 (22) | 8 (32) | 0 (0) | 1 (13) |
| ≥3 VVC episodes in past 12 mo | 2 (7) | 5 (28) | 0 (0) | 0 (0) | 2 (11) | 0 (0) |
| ≥3 BV + VVC episodes in past 12 mo | 5 (18) | 3 (17) | 5 (56) | 4 (16) | 3 (17) | 2 (25) |
| Mean BV Nugent scorea | 8.0 | NA | 6.6 | 7.8 | NA | 7.9 |
| Mean VVC scoreb | NA | 6.8 | 6.2 | NA | 7.4 | 5.5 |
Abbreviations: BV, bacterial vaginosis; NA, not applicable; SD, standard deviation; VVC, vulvovaginal candidiasis.
aGram Nugent stain score range 0–10; 4–10 confirmatory for subjects with a clinical diagnosis of BV at entry.
bVVC composite sign/symptom score range 0–18; a minimum score of 2 was required for subjects with a clinical diagnosis of VVC at entry.