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Rivista di Ostetricia e Ginecologia
Indexed/Abstracted in: EMBASE, PubMed/MEDLINE, Scopus, Emerging Sources Citation Index
Minerva Ginecologica 2017 June;69(3):245-9
Copyright © 2017 EDIZIONI MINERVA MEDICA
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