Uterine effects of raloxifene in comparison with continuous-combined hormone replacement therapy in postmenopausal women

OBJECTIVE: We sought to compare the uterine effects of raloxifene with thos e of continuous-combined hormone replacement therapy. STUDY DESIGN: This randomized, double-blind 24-month study involved 136 pos tmenopausal women who received raloxifene 150 mg/d or conjugated equine est rogens 0.625 mg/d with medroxyprogesterone acetate 2.5 mg/d. After baseline evaluations, endometrial biopsy specimens were obtained. and endometrial t hickness was measured annually by means of transvaginal ultrasonography. St atistical analyses were performed with an intention-to-treat approach. RESULTS: In the raloxifene group at the end point of the study 94.4% of bio psy specimens showed normal benign postmenopausal endometrium and 5.6% were classified as benign stimulatory endometrium. In the continuous-combined h ormone replacement therapy group at the end point of the study 78.7% of bio psy specimens showed normal benign postmenopausal endometrium, 19.1% were c lassified as benign stimulatory endometrium, and 2.1% showed benign abnorma l postmenopausal endometrium. Mean endometrial thickness was unchanged from baseline with raloxifene and was increased significantly by 0.5 mm at 12 m onths with continuous-combined hormone replacement therapy. CONCLUSION: Raloxifene 150 mg/d did not increase endometrial thickness or c ause endometrial proliferation in healthy postmenopausal women.