TABLE 2.

Change from baseline (LS means ± SE) at weeks 2, 6, 8, and 12 for the 4 co-primary endpoints (MITT population)

		% Superficial cells			% Parabasal cells			Vaginal pH			Dyspareunia (score)
TX-004HR	Week	n	LS mean ± SE	Pa	n	LS mean ± SE	Pa	n	LS mean ± SE	Pa	n	LS mean ± SE	Pa
4 μg	2	186	31.4 ± 1.50	<0.0001	186	−40.2 ± 1.72	<0.0001	186	−1.23 ± 0.06	<0.0001	145	−0.99 ± 0.07	0.0260
	6	172	18.4 ± 1.54	<0.0001	172	−39.4 ± 1.75	<0.0001	172	−1.32 ± 0.07	<0.0001	148	−1.30 ± 0.07	0.0069
	8	164	19.0 ± 1.56	<0.0001	164	−41.9 ± 1.77	<0.0001	164	−1.35 ± 0.07	<0.0001	140	−1.52 ± 0.07	0.0003
	12	170	17.5 ± 1.54	<0.0001	170	−40.6 ± 1.76	<0.0001	170	−1.32 ± 0.07	<0.0001	151	−1.52 ± 0.07	0.0149
10 μg	2	188	31.9 ± 1.50	<0.0001	188	−44.4 ± 1.71	<0.0001	188	−1.37 ± 0.06	<0.0001	147	−1.08 ± 0.07	0.0019
	6	170	16.9 ± 1.54	<0.0001	170	−43.6 ± 1.75	<0.0001	170	−1.40 ± 0.07	<0.0001	150	−1.37 ± 0.07	0.0009
	8	165	17.4 ± 1.56	<0.0001	165	−43.8 ± 1.76	<0.0001	165	−1.46 ± 0.07	<0.0001	136	−1.64 ± 0.07	<0.0001
	12	171	16.7 ± 1.54	<0.0001	171	−44.1 ± 1.75	<0.0001	171	−1.42 ± 0.07	<0.0001	154	−1.69 ± 0.07	<0.0001
25 μg	2	184	38.9 ± 1.50	<0.0001	184	−45.6 ± 1.72	<0.0001	184	−1.30 ± 0.07	<0.0001	140	−1.02 ± 0.07	0.0105
	6	173	22.7 ± 1.53	<0.0001	173	−45.6 ± 1.75	<0.0001	173	−1.48 ± 0.07	<0.0001	150	−1.48 ± 0.07	<0.0001
	8	166	23.9 ± 1.55	<0.0001	166	−45.1 ± 1.76	<0.0001	166	−1.45 ± 0.07	<0.0001	129	−1.62 ± 0.08	<0.0001
	12	174	23.2 ± 1.53	<0.0001	174	−45.6 ± 1.75	<0.0001	174	−1.34 ± 0.07	<0.0001	159	−1.69 ± 0.07	<0.0001
Placebo	2	185	6.1 ± 1.50	—	185	−7.0 ± 1.72	—	186	−0.28 ± 0.06	—	141	−0.76 ± 0.07	—
	6	176	5.4 ± 1.53	—	176	−9.2 ± 1.74	—	176	−0.30 ± 0.07	—	159	−1.03 ± 0.07	—
	8	167	6.0 ± 1.55	—	167	−7.9 ± 1.76	—	167	−0.38 ± 0.07	—	143	−1.15 ± 0.07	—
	12	172	5.6 ± 1.54	—	172	−6.7 ± 1.75	—	174	−0.28 ± 0.07	—	163	−1.28 ± 0.07	—

LS, least square; MITT, modified intent-to-treat.

^aTX-004HR versus placebo, based on mixed-effects model repeated measures.