TABLE 2.

Change from baseline to final assessment in primary outcomes (mITT population)

Mean ± SD	Placebo (n = 233)	Estradiol (n = 239)	Pa
Severity of vaginal dyspareunia	−1.2 ± 0.9	−1.5 ± 1.0	<0.001
Vaginal pH	−0.53 ± 0.92	−1.36 ± 0.89	<0.001
Percentage of vaginal cells
Superficial	1.4 ± 6.1	10.1 ± 16.7	<0.001
Parabasal	−14.6 ± 39.6	−48.5 ± 45.1	<0.001

Dyspareunia severity scores: 0 = none, 1 = mild, 2 = moderate, 3 = severe. Italic values indicate significance.

mITT, modified intent-to-treat.

^aAnalysis of covariance on rank vs placebo.