Hum. Reprod. Advance Access originally published online on April 29, 2004
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Human Reproduction, Vol. 19, No. 6, 1308-1314,
June 2004
© 2004 European Society of Human Reproduction and Embryology
Long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with uterine leiomyomas
1 Department of Obstetrics and Gynecology, University ‘Magna Graecia’ of Catanzaro, 2 Department of Molecular and Clinical Endocrinology and Oncology, University ‘Federico II’ of Naples, 3 Department of Experimental and Clinical Medicine, University ‘Magna Graecia’ of Catanzaro, 4 Department of Gynecology Obstetrics and Human Reproduction, University ‘Federico II’ of Naples and 5 Department of Obstetrics and Gynecology, University of Messina, Italy
6 To whom correspondence should be addressed at: Via Nicolardi 188, Napoli 80131, Italy. e-mail stefanopalomba{at}tin.it
BACKGROUND: Our aim was to evaluate the long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with symptomatic uterine leiomyomas. METHODS: Fifty pre-menopausal women with uterine leiomyomas were treated with leuprolide acetate depot at dose of 3.75 mg/28 days and raloxifene hydrochloride at 60 mg/day for 18 cycles. At admission and after each six cycles of treatment, bone mineral density (BMD), uterine, leiomyoma and non-leiomyoma dimensions, serum bone metabolism markers, lipid, glucose and insulin levels were evaluated. Leiomyoma-related and climacteric-like symptoms were assessed using a daily diary. RESULTS: Throughout the study, no significant change in BMD or in any bone metabolism markers was observed. A significant decrease in uterine, leiomyoma and non-leiomyoma sizes was detected in comparison with baseline already after 6 months. No other significant change was observed at the successive follow-up visits. No significant change in lipid and glucose profile was detected throughout the study. The treatments were well tolerated. All treatment withdrawals (16%, eight out of 50) were due to lack of compliance, and none to drug-related adverse experiences. CONCLUSION: GnRH agonist plus raloxifene administration is an effective and safe treatment for pre-menopausal women with uterine leiomyomas.
Key words: bone loss/GnRH a/leiomyomas/metabolism/raloxifene