Table 5.
Ospemifene 60 mg/day (n = 363)
|
Placebo (n = 63) |
p Value | |||||
---|---|---|---|---|---|---|---|
Baseline | Week 12 | Change from baseline to week 12 | Baseline | Week 12 | Change from baseline to week 12 | ||
% Superficial cells | < 0.0001 | ||||||
Median (range) | 0 (0, 5) | 5 (0, 60) | 5 (−5, 60.0) | 0 (0, 5) | 0 (0, 30) | 0 (−5, 28) | |
95% confidence interval | 5.0 to 7.0 | 0.0 to 0.0 | |||||
% Parabasal cells | < 0.0001 | ||||||
Median (range) | 50 (0, 100) | 0 (0, 100) | –40 (−100, 75) | 48 (0, 100) | 70 (0, 100) | 0 (−90, 98) | |
95% confidence interval | −55.0 to −30.0 | 0.0 to 5.0 | |||||
Vaginal pH | < 0.0001 | ||||||
Mean ± standard deviation | 6.23 ± 0.728 | 5.03 ± 0.715 | –1.21 ± 0.912 | 6.20 ± 0.749 | 6.04 ± 0.887 | –0.16 ± 0.945 |