Table 2.
Changes in Vulvovaginal Health Outcomes over Time
| Vaginal Dryness (VAS1) | Vaginal Dryness (VuAS1) | |||||||
|---|---|---|---|---|---|---|---|---|
| None | Mild | Moderate | Severe | None | Mild | Moderate | Severe | |
| BL | 0 (0%) | 15 (35%) | 11 (26%) | 17 (39%) | 10 (23%) | 12 (28%) | 10 (23%) | 11 (26%) |
| T2 | 15 (44%) | 14 (41%) | 4 (12%) | 1 (3%) | 14 (41%) | 12 (35%) | 6 (18%) | 2 (6%) |
| T3 | 18 (55%) | 12 (36%) | 2 (6%) | 1 (3%) | 18 (55%) | 8 (24%) | 5 (15%) | 2 (6%) |
| T4 | 22 (81%) | 1 (4%) | 2 (7%) | 2 (7%) | 19 (70%) | 3 (11%) | 5 (19%) | 0 (0%) |
| Vaginal Irritation (VAS3) | Vulvar Irritation (VuAS3) | |||||||
| None | Mild | Moderate | Severe | None | Mild | Moderate | Severe | |
| BL | 33 (77%) | 8 (19%) | 1 (2%) | 1 (2%) | 20 (47%) | 12 (28%) | 8 (19%) | 3 (7%) |
| T2 | 30 (88%) | 4 (12%) | 0 (0%) | 0 (0%) | 25 (74%) | 8 (23%) | 1 (3%) | 0 (0%) |
| T3 | 25 (76%) | 7 (21%) | 0 (0%) | 1 (3%) | 18 (55%) | 12 (36%) | 2 (6%) | 1 (3%) |
| T4 | 25 (93%) | 1 (4%) | 1 (4%) | 0 (0%) | 24 (89%) | 2 (7%) | 1 (4%) | 0 (0%) |
| Dyspareunia (VAS4) | Painful to Touch (VuAS4) | |||||||
| None | Mild | Moderate | Severe | None | Mild | Moderate | Severe | |
| BL | 0 (0%) | 4 (16%) | 14 (56%) | 7 (28%) | 21 (64%) | 6 (18%) | 4 (12%) | 2 (6%) |
| T2 | 4 (31%) | 4 (31%) | 2 (15%) | 3 (23%) | 20 (87%) | 1 (4%) | 2 (9%) | 0 (0%) |
| T3 | 5 (38%) | 3 (23%) 2 (15%) | 3 (23%) 2 (15%) | 2 (15%) | 21 (91%) | 2 (9%) | 0 (0%) | 0 (0%) |
| T4 | 4 (36%) | 3 (27%) | 3 (27%) | 1 (9%) | 18 (86%) | 3 (14%) | 0 (0%) | 0 (0%) |
| Vaginal Irritation (on exam) | Vulvar Irritation (on exam) | |||||||
| None | Mild | Moderate | Severe | None | Mild | Moderate | Severe | |
| BL | 28 (80%) | 5 (14%) | 2 (6%) | 0 (0%) | 23 (55%) | 12 (28%) | 5 (12%) | 2 (5%) |
| T2 | 22 (79%) | 6 (21%) | 0 (0%) | 0 (0%) | 22 (65%) | 10 (29%) | 2 (6%) | 0 (0%) |
| T3 | 25 (89%) | 2 (7%) | 1 (4%) | 0 (0%) | 24 (73%) | 7 (21%) | 1 (3%) | 1 (3%) |
| T4 | 22 (92%) | 2 (8%) | 0 (0%) | 0 (0%) | 21 (78%) | 5 (18%) | 1 (4%) | 0 (0%) |
| Vaginal pH (on exam) | Vulvar Atrophy (on exam) | |||||||
| <5 | 5-6.5 | >6.5 | None | Mild | Moderate | Severe | ||
| BL | 4 (9%) | 26 (61%) | 13 (30%) | 17 (39%) | 19 (44%) | 5 (12%) | 2 (5%) | |
| T2 | 3 (9%) | 16 (47%) | 15 (44%) | 20 (59%) | 13 (38%) | 1 (3%) | 0 (0%) | |
| T3 | 9 (27%) | 19 (58%) | 9 (27%) | 19 (58%) | 13 (39%) | 1 (3%) | 0 (0%) | |
| T4 | 4 (15%) | 17 (65%) | 5 (19%) | 12 (44%) | 13 (48%) | 2 (7%) | 0 (0%) | |
| Vaginal Stenosis (on exam) | Vestibular Irritation (on exam) | |||||||
| No | Yes | No | Yes | |||||
| BL | 31 (94%) | 2 (6%) | 27 (63%) | 16 (37%) | ||||
| T2 | 26 (93%) | 2 (7%) | 21 (64%) | 12 (36%) | ||||
| T3 | 25 (89%) | 3 (11%) | 24 (73%) | 9 (27%) | ||||
| T4 | 19 (83%) | 4 (17%) | 20 (74%) | 7 (26%) | ||||
BL, Baseline; T2, Timepoint 2; T3, Timepoint 3; T4, Timepoint 4; VAS, Vaginal Assessment Scale; VuAS, Vulvar Assessment Scale