Table 1.
Clinical and sociodemographic variables in the different clinical trial groups after randomization (n = 195)
| Testosterone n = 36 | Estrogen n = 69 | Vaginal dilator n = 31 | Lubricant gel n = 73 | p-value | |
|---|---|---|---|---|---|
| Age (mean) | 44.35 (±12.61) | 45.88 (±12.61) | 47.79 (±10.22) | 48.50 (±14.60) | 0.403c |
| BMI (mean) | 28.23 (±5.68) | 27.78 (±6.37) | 27.43 (±5.43) | 28.09 (±5.08) | 0.791c |
| Sexual intercourse per week (n) | 0.062a | ||||
| 0 | 16 (47.06%) | 51 (77.27%) | 20 (68.97%) | 46 (69.70%) | |
| 1 | 7 (20.59%) | 7 (10.61%) | 5 (17.24%) | 12 (18.18%) | |
| ≥ 2 | 11 (32.35%) | 8 (12.12%) | 4 (13.79%) | 8 (12.12%) | |
| Cylinder extension (cm) | 0.378a | ||||
| ≤ 3 cm | 23 (67.65%) | 38 (57.58%) | 15 (48.39%) | 32 (50.00%) | |
| > 3 cm | 11 (32.35%) | 28 (42.42%) | 14 (48.28%) | 32 (50.00%) | |
| Race | 0.333a | ||||
| White | 21 (61.76%) | 45 (68.18%) | 14 (48.28%) | 40 (60.61%) | |
| Non-white | 13 (38.24%) | 21 (31.82%) | 15 (51.72%) | 26 (39.39%) | |
| Marital status | 0.440a | ||||
| With partner | 23 (67.65%) | 37 (56.06%) | 18 (62.07%) | 34 (51.52%) | |
| Without partner | 11 (32.35%) | 29 (43.94%) | 11 (37.93%) | 32 (48.48%) | |
| Menopausal status | 0.202a | ||||
| Premenopausal | 24 (70.59%) | 41 (62.12%) | 20 (68.97%) | 34 (51.52%) | |
| Postmenopausal | 10 (29.41%) | 25 (37.88%) | 09 (31.03%) | 32 (48.48%) | |
| Vaginal deliveries (n) | 0.803a | ||||
| 0 | 09 (26.47%) | 15 (22.73%) | 05 (17.24%) | 13 (19.70%) | |
| ≥ 1 | 25 (73.53%) | 51 (77.27%) | 24 (82.76%) | 53 (80.30%) | |
| Vaginal stenosis after radiotherapy (CTCAE v3.0) | 0.627a | ||||
| 0 | 11 (32.35%) | 18 (27.27%) | 04 (13.79%) | 18 (27.27%) | |
| 1 | 20 (58.82%) | 44 (66.67%) | 21 (72.41%) | 43 (65.15%) | |
| 2 | 03 (8.82%) | 04 (6.06%) | 04 (13.79%) | 05 (7.58%) | |
| Type of radiotherapy | 0.395b | ||||
| EBRT | 00 (0.00%) | 00 (0.00%) | 0 (0.00%) | 02 (3.03%) | |
| Brachytherapy | 01 (2.94%) | 04 (6.06%) | 04 (13.79%) | 06 (9.09%) | |
| Both | 33 (97.06%) | 62 (93.94%) | 25 (86.21%) | 58 (87.88%) | |
| Clinical stage | 0.047a | ||||
| IB1- IIA | 08 (23.53%) | 11 (16.67%) | 07 (24.14%) | 25 (37.88%) | |
| IIB- IIIB | 26 (76.47%) | 55 (83.33%) | 22 (75.86%) | 48 (62.12%) | |
| Ovaries preserved before radiotherapy | 0.649b | ||||
| Yes | 02 (5.88%) | 09 (13.64%) | 02 (6.90%) | 07 (10.61%) | |
| No | 32 (94.12%) | 57 (86.36%) | 27 (93.10%) | 59 (89.39%) | |
| Tumoral invasion of the vaginal walls | 0.339a | ||||
| None | 21 (61.76%) | 36 (54.55%) | 18 (62.07%) | 37 (56.06%) | |
| Upper third | 3 (8.82%) | 19 (28.79%) | 03 (10.34%) | 14 (21.21%) | |
| Medium third | 7 (20.59%) | 08 (12.12%) | 05 (17.24%) | 8 (12.12%) | |
| Distal third | 3 (8.82%) | 03 (4.55%) | 03 (10.34%) | 7 (10.61%) | |
| Tumor size (cm) | 0.041a | ||||
| ≤ 3 cm | 11 (32.35%) | 17 (25.76%) | 7 (24.14%) | 31 (46.97%) | |
| > 3 cm | 23 (67.65%) | 49 (74.24%) | 22 (75.86%) | 35 (53.03%) | |
| Surgery | 0.409a | ||||
| Yes | 03 (8.82%) | 10 (15.15%) | 06 (20.69%) | 14 (21.21%) | |
| No | 31 (91.18%) | 56 (84.85%) | 23 (79.31%) | 52 (78.79%) | |
| Type of applicator | 0.365a | ||||
| Cylinder | 11 (32.35%) | 27 (41.54%) | 14 (48.28%) | 32 (50.00%) | |
| Ring | 23 (67.65%) | 38 (58.46%) | 15 (51.72%) | 32 (50.00%) | |
| Chemotherapy | 0.073a | ||||
| Yes | 27 (79.41%) | 59 (89.39%) | 22 (75.86%) | 47 (71.21%) | |
| No | 07 (20.59%) | 07 (10.61%) | 07 (24.14%) | 19 (28.79%) |
BMI Body mass index
EBRT external beam radiotherapy
CTCAE v3.0 Common Criteria for Adverse Events Version 3.0 scale
aChi-square test
bFisher’s exact test
cKruskal-Wallis test