[Clinical study of the action of a new molecule, veralipride, on menopausal psychofunctional disorders (author's transl)].
A preliminary open study was conducted in 20 women with menopausal sudden flushes to assess the effect of veralipride, administered as 100 mg/day for 20 days. In 15 cases, sudden flushes and night sweats were no longer present following treatment and behaviour had considerably improved. In the remaining 5 cases, sudden flushes were reduced in number and severity. A second study was then conducted in 40 women with the same symptoms, to compare the efficacy of veralipride and placebo under double-blind conditions. Successful results were obtained in 15 patients after veralipride and 5 after placebo, while treatment was a failure in 5 patients after veralipride and 15 after placebo. The difference is very significant in favor of veralipride (p < 0,01). Best results were obtained on sudden flushes, followed by mood and behavior disorders, with less consistent results in headache, pruritus vulvae, and palpitations. Clinical tolerance was good as only 4 cases of difficulty in falling asleep, 3 cases of mammary tension, and 2 cases of dryness of the mouth were reported. Biological parameters and vaginal smears were not modified by treatment.
D000328:Adult; D002979:Climacteric / Q000187:drug effects; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D010919:Placebos; D011602:Psychophysiologic Disorders / Q000188:drug therapy*; D013469:Sulpiride / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use
D010919:Placebos; D013469:Sulpiride; C027429:veralipride
Etude clinique de l'activité d'une nouvelle molécule, le véralipride, sur les troubles psycho-neuro-végétatifs de la ménopause.