A clinical trial of the effects of tibolone administered with gonadotropin-releasing hormone analogues for the treatment of uterine leiomyomata

Stefano Palomba, Pietro Affinito, Giovanni A. Tommaselli, Carmine Nappi

Research output: Contribution to journalArticle

Abstract

Objective: To evaluate the effects of tibolone therapy in association with GnRH-a on uterine leiomyomata, on climacteric-like symptoms, on bone metabolism, and on the lipid profile. Design: A prospective, randomized, double-blind, placebo-controlled, clinical trial. Setting: Department of Gynecology and Obstetrics, University of Naples 'Federico II,' Naples, Italy. Patient(s): Fifty women with symptomatic uterine leiomyomata. Intervention(s): Six months of treatment with leuprolide acetate (3.75 mg every 28 days IM) combined with daily placebo tablets (group A) or with 2.5- mg of tibolone per os (group B). Main Outcome Measure(s): Uterine and uterine leiomyomata sizes, lumbar spine bone mineral density, biochemical markers of bone metabolism, lipid profile, and myoma-related symptoms were measured at baseline and after 6 months of treatment. Daily symptom diary in which hot flushes and vaginal bleeding episodes were recorded. Result(s): No differences between the 2 groups in uterine and uterine leiomyomata size and myoma-related symptoms were detected. After 6 months of treatment, there were statistically significant changes from baseline in bone mineral density and in biochemical markers of bone metabolism in group A but not in group B. Vasomotor symptoms were significantly lower in group B than in group A. There was a statistically significant increase (P

Original languageEnglish
Pages (from-to)111-118
Number of pages8
JournalFertility and Sterility
Volume70
Issue number1
DOIs
Publication statusPublished - Jul 1998

Keywords

  • Add-back therapy
  • GnRH-a
  • Tibolone
  • Uterine leiomyomata

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

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