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

Stefano Palomba, Francesco Orio, Tiziana Russo, Angela Falbo, Teresa Cascella, Patrizia Doldo, Carmine Nappi, Gaetano Lombardi, Pasquale Mastrantonio, Fulvio Zullo

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1308-1314
Number of pages7
JournalHuman Reproduction
Volume19
Issue number6
DOIs
Publication statusPublished - Jun 2004

Keywords

  • Bone loss
  • GnRH a
  • Leiomyomas/Metabolism/Raloxifene

ASJC Scopus subject areas

  • Physiology
  • Developmental Biology
  • Obstetrics and Gynaecology
  • Reproductive Medicine

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