Table 4.

Endometrial thickness changes during the 52-week treatment period*. Data are given as mean ± standard deviation. Change from baseline in endometrial thickness defined as thickness at week 26 or week 52 minus thickness at baseline

Observed value time point	Ospemifene 60 mg/day	Placebo
Baseline (screening)*
n	364	62
Endometrial thickness (mm)	2.1 ± 0.8	2.0 ± 0.9
Week 12
n	315	58
Endometrial thickness (mm)	2.5 ± 1.5	2.3 ± 1.7
Change from baseline (mm)	0.44 ± 1.7	0.31 ± 1.5
Week 26
n	311	57
Endometrial thickness (mm)	2.6 ± 1.5	2.2 ± 1.0
Change from baseline (mm)	0.51 ± 1.6	0.22 ± 1.3
Week 52
n	294	55
Endometrial thickness (mm)	2.8 ± 1.4	2.1 ± 1.0
Change from baseline (mm)	0.75 ± 1.5	0.17 ± 1.3

*, Observed cases