Veralipride for hot flushes induced by a gonadotropin-releasing hormone agonist: A controlled study

P. Vercellini, P. Sacerdote, L. Trespidi, B. Manfredi, A. E. Panerai, P. G. Crosignani

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objectives: To evaluate the efficacy of veralipride, a benzamide derivative, in the treatment of hot flushes induced by GnRH agonists (GnRH- a) and to study peripheral blood mononuclear cell β-endorphin concentrations during drug administration. Design: Randomized, placebo-controlled, double- blind trial. Setting: Academic department of obstetrics and gynecology. Patients: Forty women of mean age 43 ± 5 years who experienced disturbing hot flushes during a 4-month course of tryptorelin depot for myoma-associated menorrhagia. Interventions: Treatment with oral veralipride 100 mg/d (20 subjects) or matching placebo (20 subjects) during the third month of GnRH-a administration. Main Outcome Measures: Modifications of frequency and severity of hot flushes as shown by a 0 to 6-point vasomotor scoring system and variations of β-endorphin levels in peripheral blood mononuclear cells. Results: Two subjects in each group dropped out of the study. The median (range) vasomotor score at the end of the second month of treatment was 4 (3 to 6) in both the veralipride and placebo group. At the end of the third and fourth months the median (range) scores were, respectively, 2 (0 to 6) versus 4 (1 to 6) and 2 (0 to 5) versus 4 (1 to 6). No significant variations in mononuclear cell β-endorphin concentrations were recorded. Serum PRL levels rose from 11.7 ± 5.7 to 132.3 ± 65.0 ng/mL (conversion factor to SI unit, 1.0) during veralipride administration and returned to 10.6 ± 3.7 ng/mL after drug withdrawal. Conclusion: Veralipride reduced vasomotor symptoms induced by a GnRH-a. Transient hyperprolactinemia was the main side effect observed. The mode of action of the drug in GnRH-a-treated patients and possible interactions with endogenous opioid peptides need further elucidation.

Original languageEnglish
Pages (from-to)938-942
Number of pages5
JournalFertility and Sterility
Volume62
Issue number5
Publication statusPublished - 1994

Fingerprint

veralipride
Gonadotropin-Releasing Hormone
Endorphins
Placebos
Vasomotor System
Blood Cells
International System of Units
Pharmaceutical Preparations
Menorrhagia
Myoma
Hospital Obstetrics and Gynecology Department
Hyperprolactinemia
Opioid Peptides
Gynecology
Therapeutics
Outcome Assessment (Health Care)

Keywords

  • β- endorphin
  • gonadotropin-releasing hormone agonists
  • Hot flushes
  • veralipride

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

Veralipride for hot flushes induced by a gonadotropin-releasing hormone agonist : A controlled study. / Vercellini, P.; Sacerdote, P.; Trespidi, L.; Manfredi, B.; Panerai, A. E.; Crosignani, P. G.

In: Fertility and Sterility, Vol. 62, No. 5, 1994, p. 938-942.

Research output: Contribution to journalArticle

Vercellini, P. ; Sacerdote, P. ; Trespidi, L. ; Manfredi, B. ; Panerai, A. E. ; Crosignani, P. G. / Veralipride for hot flushes induced by a gonadotropin-releasing hormone agonist : A controlled study. In: Fertility and Sterility. 1994 ; Vol. 62, No. 5. pp. 938-942.
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