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

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.