TABLE 3.
Change from baseline to week 12 in secondary outcomes (mITT population)
Mean ± SD | Placebo (n = 233) | Estradiol (n = 239) | Pa |
Atrophyb | −0.5 ± 0.8 | −0.9 ± 0.8 | <0.001 |
Pallorb | −0.6 ± 0.8 | −0.9 ± 0.8 | <0.001 |
Drynessb | −0.5 ± 0.9 | −0.9 ± 0.9 | <0.001 |
Friabilityb | −0.6 ± 1.0 | −1.0 ± 1.0 | <0.001 |
Petechiaeb | −0.3 ± 0.8 | −0.6 ± 0.9 | <0.001 |
pH | −0.53 ± 0.93 | −1.35 ± 0.89 | <0.001 |
Percentage of vaginal cells | |||
Superficial | 1.2 ± 5.4 | 10.5 ± 17.2 | <0.001 |
Parabasal | −14.9 ± 39.9 | −48.2 ± 45.7 | <0.001 |
Italic values indicate significance.
mITT, modified intent-to-treat.
aAnalysis of covariance on rank vs placebo.
bVisual inspection score: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.