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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

Stefano Palomba1,6, Francesco Orio, Jr2, Tiziana Russo1, Angela Falbo1, Teresa Cascella2, Patrizia Doldo3, Carmine Nappi4, Gaetano Lombardi2, Pasquale Mastrantonio5 and Fulvio Zullo1

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


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