A potent non-hormonal option for the treatment of postmenopausal vaginal dryness with high tolerability

Abstract

Genitourinary syndrome of menopause (GSM) is considered a chronic condition with urogenital implications caused by estrogen deficiency typically after onset of menopause. Vaginal dryness accompanied by burning and itching is one of the most prevalent and bothersome symptoms of GSM. Affected women suffer from reduced lubrication and, those who are sexually active, also from dyspareunia. Non-hormonal therapies, such as vaginal moisturizers or lubricants, are recommended as first-line treatments to achieve the relief of symptoms, while improving the quality of life. Due to emerging demand for pessary formulations, we evaluated the efficacy and tolerability of a non-hormonal pessary containing nourishing lipids and lactic acid. Therefore, a prospective, open-label clinical trial was performed, including 79 postmenopausal women with symptoms of vaginal dryness. The patients applied one pessary daily within the first week followed by two pessaries per week for the next 31 days. After 38 days of treatment, a treatment free period of 6 days completed the trial. Subjective symptoms of vaginal dryness, such as feeling of dryness, itching, burning and pain (unrelated and related to sexual intercourse), were assessed at every visit, while the objective vaginal health index (VHI) was only examined at beginning and end of treatment. Data regarding the impact on patients’ quality of life, efficacy and tolerability were evaluated using various questionnaires. Our data show that symptoms of vulvovaginal dryness, itching, burning and pain as well as dyspareunia significantly decreased from baseline to end of treatment (day 38) and beyond. Quality of life assessed by DIVA (day-to day impact of vaginal aging) questionnaire, and VHI also clearly improved over the study period. The tolerability was rated as 'good' or 'very good' by most of the patients and by the investigator. No serious adverse events and only a low number of mild adverse events rated as related to the vaginal pessary were reported. Overall, this study identifies the investigated non-hormonal pessary as a potent option for the treatment of postmenopausal symptoms of vaginal dryness with a high tolerability. It can therefore be recommended as a first-line treatment that contributes to maintaining a healthy vaginal environment in postmenopausal women.