Table 3.

Endometrium histological biopsy characteristics: baseline vs. week 52 (last observation carried forward)*. Data are given as n (%)

Histological characteristics†	Ospemifene 60 mg/day (n = 364)	Placebo (n = 62)
	Baseline	Week 52‡	Baseline	Week 52
Tissue insufficient for diagnosis	59 (16.2)	27 (8.7)	8 (12.9)	11 (19.6)
Atrophic	300 (82.4)	267 (86.1)	52 (83.9)	45 (80.4)
Inactive	1 (0.3)	1 (0.3)	1 (1.6)	0 (0)
Weakly proliferative	1 (0.3)	7 (2.3)	0 (0)	0 (0)
Active proliferative	0 (0)	3 (1.0)	0 (0)	0 (0)
Hyperplasia	0 (0)	1 (0.3)	0 (0)	0 (0)

*, Safety population;

^†, assessments of biopsies were made according to predefined and generally accepted microscopic criteria (Blaustein's classification)²⁹;

^‡, percentages at week 52 are of the number of subjects with last observation carried forward data; the numbers of women for each parameter at week 52 are different for the calculation of percentage

Additional histological biopsy results: ospemifene, baseline – two cases of atypical epithelial proliferation and one case of endometritis, chronic; ospemifene, week 52 – three cases of endometrial polyp, atrophic type; one case of polyp, functional endometrial type; one case of endocervical polyp. In addition, placebo, baseline – one case of endometrial polyp. Further expert review of the atrophic and functional endometrial polyp slides determined that these did not represent true polyps