OBJECTIVE: To evaluate the effects of raloxifene administration on uterine leiomyoma size in premenopausal women. DESIGN: Prospective, randomized, open-label, controlled clinical trial. SETTING:Tertiary care unit, University of Vienna, Austria. PATIENT(S): Twenty-five premenopausal women with uterine leiomyomas. INTERVENTION(S): Three months of treatment with raloxifene (180 mg/d) or no treatment. MAIN OUTCOME MEASURE(S): Baseline to end point percent change difference in leiomyoma volume between the therapy and control groups. RESULT(S): Raloxifene treatment prevented the progression of uterine leiomyomas. Compared with no medical intervention, raloxifene resulted in a decrease of myoma volume. Raloxifene was clinically well tolerated. No significant differences were detected in symptoms related to leiomyomas and hormonal status. CONCLUSION(S): In premenopausal women, high-dose raloxifene is well tolerated and inhibits the growth of leiomyomas.
RCT Entities:
OBJECTIVE: To evaluate the effects of raloxifene administration on uterine leiomyoma size in premenopausal women. DESIGN: Prospective, randomized, open-label, controlled clinical trial. SETTING: Tertiary care unit, University of Vienna, Austria. PATIENT(S): Twenty-five premenopausal women with uterine leiomyomas. INTERVENTION(S): Three months of treatment with raloxifene (180 mg/d) or no treatment. MAIN OUTCOME MEASURE(S): Baseline to end point percent change difference in leiomyoma volume between the therapy and control groups. RESULT(S): Raloxifene treatment prevented the progression of uterine leiomyomas. Compared with no medical intervention, raloxifene resulted in a decrease of myoma volume. Raloxifene was clinically well tolerated. No significant differences were detected in symptoms related to leiomyomas and hormonal status. CONCLUSION(S): In premenopausal women, high-dose raloxifene is well tolerated and inhibits the growth of leiomyomas.
Authors: Samantha J Owens; Thomas W Weickert; Tertia D Purves-Tyson; Ellen Ji; Christopher White; Cherrie Galletly; Dennis Liu; Maryanne O'Donnell; Cynthia Shannon Weickert Journal: Mol Neuropsychiatry Date: 2018-11-20