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Hum. Reprod. Advance Access published online on April 29, 2004
Human Reproduction, doi:10.1093/humrep/deh296
© 2004 by European Society of Human Reproduction and Embryology
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Received February 17, 2004
Accepted April 8, 2004

Article

Long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with uterine leiomyomas

Stefano Palomba 1*, Francesco Orio Jr 2, Tiziana Russo 3, Angela Falbo 3, Teresa Cascella 2, Patrizia Doldo 4, Carmine Nappi 5, Gaetano Lombardi 2, Pasquale Mastrantonio 6, Fulvio Zullo 3

1 Department of Obstetrics and Gynecology, University ‘Magna Graecia’ of Catanzaro, Italy; Via Nicolardi 188, Napoli 80131, Italy
2 Department of Molecular and Clinical Endocrinology and Oncology, University ‘Federico II’ of Naples, Italy
3 Department of Obstetrics and Gynecology, University ‘Magna Graecia’ of Catanzaro, Italy
4 Department of Experimental and Clinical Medicine, University ‘Magna Graecia’ of Catanzaro, Italy
5 Department of Gynecology Obstetrics and Human Reproduction, University ‘Federico II’ of Naples, Italy
6 Department of Obstetrics and Gynecology, University of Messina, Italy

* To whom correspondence should be addressed. E-mail: stefanopalomba{at}tin.it.


  Abstract

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: Key words: bone loss/GnRH a/leiomyomas/metabolism/raloxifene


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