Objective: To evaluate the effects of raloxifene administration on uterine and uterine leiomyoma sizes in postmenopausal women.
Design: Prospective randomized, double-blind, placebo-controlled clinical trial.
Setting: Department of Gynecology, Obstetrics, and Pathophysiology of Human Reproduction, University of Naples "Federico II", Italy.
Patient(s): Seventy spontaneous postmenopausal women affected by uterine leiomyomas.
Intervention(s): Twelve cycles (of 28 days each) of treatment with raloxifene (60 mg daily per os) or placebo.
Main outcome measure(s): At entry and at every 3 cycles, uterine and uterine leiomyoma dimensions were measured by means of transvaginal ultrasound. The difference between uterine and leiomyoma volumes (Delta size) was calculated in all subjects. The characteristics of uterine bleeding and the side effects of the treatments were assessed using a daily diary.
Result(s): After 6, 9, and 12 cycles of therapy, in subjects treated with raloxifene, the mean uterine and uterine leiomyoma size were significantly decreased, and the mean Delta size significantly increased in comparison with basal values and the placebo group. No significant differences in uterine bleeding were detected between the two groups.
Conclusion(s): In postmenopausal women raloxifene appears to act selectively on uterine leiomyomas, reducing their size.