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ORIGINAL ARTICLE
Minerva Ginecologica 2019 October;71(5):353-8
DOI: 10.23736/S0026-4784.19.04398-3
Copyright © 2019 EDIZIONI MINERVA MEDICA
lingua: Inglese
A randomized single-blind placebo-controlled study of a Visnadine Emulgel formulation on healthy postmenopausal women
Adele SPARAVIGNA 1, Alberto CAPUTO 2 ✉, Alice NATOLI 2, Clara MANDELLI 3
1 Derming Institute of Clinical Research and Bioengineering, Milan, Italy; 2 Istituto di Evoluzione Sessuale (IES), Milan, Italy; 3 AlmaMed, Milan, Italy
BACKGROUND: There is a growing interest on women’ sexual function improvement provided by topical vulvar application of Visnadine, a natural extractive substance with putative vasodilatory properties. Aims of this study were to evaluate: 1) the vasokinetic activity of a Visnadine Emulgel on mucosal genitalia of 15 healthy postmenopausal women clinically and by instrumental non-invasive analysis; 2) the treatment efficacy by volunteers’ judgment regarding to subjective comfort, pleasant warmth, lubrication grade, pinching and burning vulvar sensations.
METHODS: Fifteen informed healthy female volunteers with menopause were enrolled in the study, with a single blind controlled study versus placebo corresponding to one single application of the emulgel product (active or placebo) on external genitalia.
RESULTS: Visnadine Emulgel single application determined a significant increase of vulvar hyperemia, evaluated both clinically and instrumentally, accompanied by a significant increase of local turgor versus placebo. The volunteers reported a pleasant comfort sensation.
CONCLUSIONS: The topical use of Visnadine on female external genitalia may increase regional vascularization affecting turgidity and sensorial threshold of the area of application.
KEY WORDS: Ammi; Visnadin; Lubrication; Vasodilator agents; Orgasm; Sexual health