. 2017 Aug 25;24(9):1003–1010. doi: 10.1097/GME.0000000000000880

TABLE 3.

Change from baseline to weeks 2, 6, 8, and week 12 in vaginal parameters in the modified intent-to-treat (MITT) population

Vaginal parameters	TX-004HR 4 μg (n = 186)		TX-004HR 10 μg (n = 188)		TX-004HR 25 μg (n = 186)		Placebo (n = 187)
Vaginal color
Baseline score, mean ± SD		1.8 ± 0.61		1.7 ± 0.59		1.8 ± 0.60		1.7 ± 0.64
LS mean (SE)	n		n		n		n
Wk 2	185	−0.69 (0.05)^a	187	−0.77 (0.05)^a	184	−0.78 (0.05)^a	186	−0.40 (0.05)
Wk 6	172	−0.82 (0.05)^a	170	−0.93 (0.05)^a	173	−0.89 (0.05)^a	176	−0.50 (0.05)
Wk 8	164	−0.98 (0.05)^a	165	−1.04 (0.05)^a	166	−0.99 (0.05)^a	167	−0.50 (0.05)
Wk 12	171	−0.97 (0.05)^a	173	−1.06 (0.05)^a	175	−0.96 (0.05)^a	175	−0.60 (0.05)
Vaginal epithelial integrity
Baseline score, mean ± SD		1.6 ± 0.84		1.4 ± 0.83		1.5 ± 0.77		1.5 ± 0.84
LS mean (SE)	n		n		n		n
Wk 2	185	−0.85 (0.05)^a	187	−0.87 (0.05)^a	184	−0.93 (0.05)^a	186	−0.53 (0.05)
Wk 6	172	−0.97 (0.05)^a	170	−1.02 (0.05)^a	173	−1.01 (0.05)^a	176	−0.61 (0.05)
Wk 8	164	−1.03 (0.05)^a	165	−1.08 (0.05)^a	166	−1.08 (0.05)^a	167	−0.66 (0.05)
Wk 12	171	−0.97 (0.05)^a	173	−1.07 (0.05)^a	175	−1.01 (0.05)^a	175	−0.60 (0.05)
Vaginal epithelial surface thickness
Baseline score, mean ± SD		1.9 ± 0.67		1.8 ± 0.63		1.9 ± 0.59		1.9 ± 0.65
LS mean (SE)	n		n		n		n
Wk 2	185	−0.76 (0.05)^a	187	−0.76 (0.05)^a	184	−0.76 (0.05)^a	186	−0.40 (0.05)
Wk 6	172	−0.85 (0.05)^a	170	−0.93 (0.05)^a	173	−0.90 (0.05)^a	176	−0.53 (0.05)
Wk 8	164	−0.96 (0.05)^a	165	−1.04 (0.05)^a	166	−0.99 (0.05)^a	167	−0.59 (0.05)
Wk 12	171	−0.98 (0.05)^a	173	−1.03 (0.05)^a	175	−0.94 (0.05)^a	175	−0.61 (0.05)
Vaginal secretions
Baseline score, mean ± SD		1.8 ± 0.68		1.7 ± 0.66		1.7 ± 0.63		1.8 ± 0.63
LS mean (SE)	n		n		n		n
Wk 2	185	−0.79 (0.05)^b	187	−0.83 (0.05)^a	184	−0.86 (0.05)^a	186	−0.54 (0.05)
Wk 6	172	−0.90 (0.05)^b	170	−0.95 (0.05)^a	173	−0.97 (0.05)^a	176	−0.60 (0.05)
Wk 8	164	−1.00 (0.05)^a	165	−1.04 (0.05)^a	166	−1.06 (0.05)^a	167	−0.63 (0.05)
Wk 12	171	−1.01 (0.05)^a	173	−1.06 (0.05)^a	175	−1.04 (0.05)^a	175	−0.64 (0.05)

Data are mean ± SD unless otherwise noted.

LS, least square; SD, standard deviation; SE, standard error.

^aP < 0.0001 versus placebo; ^bP < 0.001.