• Stefano Palomba, Francesco Orio, Tiziana Russo, Angela Falbo, Teresa Cascella, Patrizia Doldo, Carmine Nappi, Gaetano Lombardi, Pasquale Mastrantonio, and Fulvio Zullo.
• Department of Obstetrics and Gynecology, University 'Magna Graecia' of Catanzaro, Italy. stefanopalomba@tin.it
• Hum. Reprod. 2004 Jun 1; 19 (6): 1308-14.

BackgroundOur aim was to evaluate the long-term effectiveness and safety of GnRH agonist plus raloxifene administration in women with symptomatic uterine leiomyomas.MethodsFifty 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.ResultsThroughout 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.ConclusionGnRH agonist plus raloxifene administration is an effective and safe treatment for pre-menopausal women with uterine leiomyomas.

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