An effective non-hormonal option with high tolerability for mild to moderate symptoms of vaginal dryness associated with menopause

• Published in: Maturitas 2024-07, Vol.185, p.107978, Article 107978
• Main Authors: Eichler, Susann, Panz, Mareike, Harder, Anastasia, Masur, Clarissa, Häuser, Manuel, Wiesche, Erik Schulze zur
• Format: Article
• Language: English
• Subjects: (Post)menopause; Aged; Atrophic vaginitis; Dyspareunia; Dyspareunia - drug therapy; Dyspareunia - etiology; Dyspareunia - therapy; Female; Humans; Menopause; Middle Aged; Non-hormonal vaginal remedy; Pessaries; Postmenopause; Prospective Studies; Quality of Life; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome; Vagina - drug effects; Vagina - pathology; Vaginal Diseases - drug therapy; Vaginal Diseases - therapy; Vaginal dryness
• ISSN: 0378-5122; 1873-4111; 1873-4111
• DOI: 10.1016/j.maturitas.2024.107978

•Symptoms of vaginal dryness often have a severe impact on daily and sexual life.•In this study, a novel non-hormonal pessary reduced the severity of dryness, including dyspareunia.•Within 24 h of initial use, 77.7 % of women reported noticeable relief.•88.2 % observed a treatment effect lasting 3 or more days after the last use.•Objective improvements of vaginal health, including tissue condition and pH, were observed in this study. The efficacy and tolerability of a non-hormonal pessary (that forms an oil-in-water emollient with the vaginal fluid) were assessed for the treatment of symptoms of vaginal dryness associated with menopause. Seventy-nine postmenopausal women (mean age 60.8 ± 6.5 years) with mild to moderate symptoms of vaginal dryness (including dyspareunia) were enrolled in this open-label, prospective, post-market clinical follow-up trial, conducted in 2022 by one research center in Germany. The investigational pessary was applied for the first 7 days once daily and the subsequent 31 days twice a week, at bedtime. A treatment-free period of 6 days completed the trial. During the trial, participants filled out questionnaires that enabled the calculation of a total severity score for subjective symptoms of atrophy-related vaginal dryness and impairment of daily as well as sexual life. Furthermore, vaginal health index and safety were studied. A rapid and significant reduction in the severity scores for symptoms was observed over the 38-day course of treatment and beyond. Quality of life assessed by DIVA (day-to-day impact of vaginal aging) questionnaire, dyspareunia and vaginal health index also clearly improved. The tolerability was mainly rated as “good to very good” by the investigator and 94.9 % of participants. The vast majority were very satisfied with the simple and pleasant handling. No serious adverse events occurred. Overall, the presented data suggest that the investigated non-hormonal pessary is an effective and well tolerated treatment option for vaginal symptoms associated with dryness, thus improving quality of life for women, even those who are sexually active. ClinicalTrials.gov identifier NCT05211505.