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

Fingerprint

tibolone
Leiomyoma
Gonadotropin-Releasing Hormone
Clinical Trials
Myoma
Lipid Metabolism
Bone and Bones
Bone Density
Biomarkers
Placebos
Leuprolide
Hospital Obstetrics and Gynecology Department
Uterine Hemorrhage
Controlled Clinical Trials
Therapeutics
Gynecology
Italy
Tablets
Spine
Outcome Assessment (Health Care)

Keywords

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

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

A clinical trial of the effects of tibolone administered with gonadotropin-releasing hormone analogues for the treatment of uterine leiomyomata. / Palomba, Stefano; Affinito, Pietro; Tommaselli, Giovanni A.; Nappi, Carmine.

In: Fertility and Sterility, Vol. 70, No. 1, 07.1998, p. 111-118.

Research output: Contribution to journalArticle

Palomba, Stefano ; Affinito, Pietro ; Tommaselli, Giovanni A. ; Nappi, Carmine. / A clinical trial of the effects of tibolone administered with gonadotropin-releasing hormone analogues for the treatment of uterine leiomyomata. In: Fertility and Sterility. 1998 ; Vol. 70, No. 1. pp. 111-118.
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