ORIGINAL ARTICLE   Free access

Minerva Ginecologica 2017 June;69(3):245-9

DOI: 10.23736/S0026-4784.17.04015-1

Copyright © 2017 EDIZIONI MINERVA MEDICA

lingua: Inglese

Efficacy and tolerability of a plant-based, multi-component cream (Ginetrox®) in vulvovaginal disorders of the genitourinary syndrome during menopause

Roberto MARRAI ¹, Giovanni LISSI ², Stefano TOGNI ³, Giada MARAMALDI ³, Marco BARBARA ⁴, Luca GIACOMELLI ⁵ ✉

¹ Obstetrics and Gynecology Unit, G. Pasquinucci Hospital, Massa, Italy; ² Funziona Srl, Milan, Italy; ³ Indena SpA, Milan, Italy; ⁴ University of Palermo, Palermo, Italy; ⁵ Department of Surgical Sciences and Integrated Diagnostics, School of Medicine, University of Genoa, Genoa, Italy

BACKGROUND: Genitourinary syndrome of menopause (GSM) is a symptomatic condition including vaginal dryness, irritation, dyspareunia and recurrent urinary tract infections which affects 40-54% of post-menopausal women. Although several estrogen-based therapies are available, it is generally preferable to avoid hormonal therapy, particularly in women with mild symptoms or at risk for estrogen-responsive neoplasia. Therefore, the most common treatment options are over-the-counter vaginal creams for symptomatic relief.
METHODS: Thirty-three postmenopausal women suffering from GSM were enrolled in this observational study. A multi-component cream (Ginetrox®, Indena, Milan, Italy) was applied on the vestibular area of the vagina for three months. The primary endpoints were: vaginal burning and/or pain, assessed by Visual Analog Scale and dyspareunia, assessed using the Marinoff Score. As a secondary endpoint, vestibular health was evaluated through a four-point scale. Side effects and adherence to treatment were also recorded.
RESULTS: Statistically significant improvement was observed in pain scores and dyspareunia at the end of the treatment compared to baseline values. The vestibular health index significantly decreased after 3 months. Tolerability was acceptable.
CONCLUSIONS: This preliminary study suggests that the plant-based, multi-component cream Ginetrox® could be effective and safe in counteracting menopause-related vaginal discomfort symptoms.

KEY WORDS: Female urogenital diseases - Menopause - Vaginal creams, foams, and jellies - Dyspareunia - Tamarindus - Madecassoside