Human Reproduction, Vol. 17, No. 12, 3213-3219,
December 2002
© 2002 European Society of Human Reproduction and Embryology
Effectiveness of combined GnRH analogue plus raloxifene administration in the treatment of uterine leiomyomas: a prospective, randomized, single-blind, placebo-controlled clinical trial
1 Department of Obstetrics & Gynecology, University ‘Magna Graecia’ of Catanzaro, Catanzaro, 2 Department of Endocrinology and Experimental Oncology and 3 Department of Gynecology, Obstetrics and Human Reproduction, University of Naples ‘Federico II’, Naples, 4 Department of Obstetrics and Gynecology, University ‘Tor Vergata’ of Rome, and 5 Department of Obstetrics and Gynecology, University of Rome ‘Campus Biomedico’, Rome, Italy
BACKGROUND: Raloxifene hydrochloride is a synthetic non-steroidal drug used for the prevention and treatment of post-menopausal osteoporosis. Pre-clinical and clinical data have shown that raloxifene may have a beneficial effect on leiomyomas. The aim of this prospective single-blind, randomized, placebo-controlled clinical trial was to evaluate the effectiveness of the addition of raloxifene to GnRH analogues on uterine, leiomyoma, and non-leiomyoma sizes, and on the occurrence of leiomyoma-related symptoms. METHODS: After randomization using a computer-generated list, 100 pre-menopausal women with symptomatic uterine leiomyomas received either leuprolide acetate depot plus raloxifene 60 mg daily (group A) or leuprolide plus placebo tablet (group B) for six cycles of 28 days. At baseline and after treatment, uterine, leiomyoma and non-leiomyoma sizes, and leiomyoma-related symptoms were evaluated for each woman. Analysis was by intention-to-treat method. RESULTS: After six cycles of treatment, a significant decrease in uterine, leiomyoma, and non-leiomyoma sizes was detected in both groups in comparison with baseline. At the same time, no significant difference in uterine and non-leiomyoma sizes was observed between the groups. Leiomyoma sizes were significantly (P < 0.05) lower in group A than in group B. No difference was observed in leiomyoma-related symptoms between groups throughout the study period. CONCLUSIONS: In women treated with GnRH analogue, the raloxifene administration induces a higher reduction of leiomyoma sizes.
Key words: add-back therapy/fibroids/GnRH analogue/leiomyomas/raloxifene
6 To whom correspondence should be addressed at: Via Nicolardi 188, Napoli 80131, Italy. E-mail: stefanopalomba{at}tin.it
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