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ST A R PA PE R Endometrial effects of tibolone in elderly, osteoporotic women Ettinger B, Kenemans P, Johnson SR, Mol-Arts M, Van Os S, Seifert W, Verweij PJ, Cummings SR Obstet Gynecol 2008;112:653–9 Objective. To investigate endometrial effects of tibolone administered to postmenopausal women for three years. Methods. A total of 3500 postmenopausal women aged 60–85 years with a uterus and with osteoporosis were randomly given 1.25 mg tibolone orally daily, or placebo. Endometrial thickness in all women was measured, and 635 women with vaginal bleeding or endometrial thickness more than 4 mm had biopsies. Results. In the first year endometrial thickness increased by 1 mm in the tibolone group, with no further increases during the next two years. Biopsies showed endometrial hyperplasia in ,1%. In 15% of women with an endometrial polyp, the tibolone patients were more than twice as likely to show hyperplasia within the polyp. A slight increase in grade 1 endometrioid adenocarcinoma was found among women receiving tibolone. Vaginal bleeding was 11% in the tibolone group and 3% in the placebo group. Conclusion. Tibolone treatment during three years minimally increased endometrial thickness, hyperplastic polyps, endometrial carcinoma and vaginal bleeding.