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Table 1 Clinical and sociodemographic variables in the different clinical trial groups after randomization (n = 195)

From: Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial

  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%)  
  1. BMI Body mass index
  2. EBRT external beam radiotherapy
  3. CTCAE v3.0 Common Criteria for Adverse Events Version 3.0 scale
  4. aChi-square test
  5. bFisher’s exact test
  6. cKruskal-Wallis test