New vaginal moisturizer is well-accepted and reduces symptoms related to the genitourinary syndrome of menopause in Brazilian women: O novo hidratante vaginal é bem aceito e reduz os sintomas relacionados à síndrome geniturinária da menopausa nas mulheres brasileiras

Abstract

Objectives: To evaluate the effectiveness and acceptability of a new vaginal moisturizer composed of a combination of humectants, moisturizers, bioadhesives, and viscosity polymers (sodium hyaluronate 0.1%, polycarbophil 1.5%, carbomer 1.5%, and glycerin 1%) for relief of vulvovaginal symptoms associated with genitourinary syndrome of menopause in Brazilian postmenopausal women. Methods: An open clinical trial was performed with 33 postmenopausal women between 47 and 68 years of age with genitourinary syndrome of menopause symptoms such as vaginal dryness accompanied by pain or discomfort during intercourse. Clinical efficacy in relieving symptoms of genitourinary syndrome of menopause and acceptability were assessed using a Likert scale questionnaire. Efficacy and safety were assessed through gynecological examination, which included visual inspection of the epithelium and vaginal contents, and determination of vaginal pH. Wilcoxon's non-parametric test and paired Student's t-test were used for statistical analyses.Results: After 3 weeks of treatment, most participants reported improvement in GSM symptoms like vaginal dryness (p<0.001), discomfort during or after sexual intercourse (p<0.001), pain during or after sexual intercourse (p<0.001), vaginal odor (p=0.047) and itching (p=0.032) and good acceptability of the moisturizer. There was no alteration in the vaginal health index; however, a reduction in vaginal inflammation (p=0.046) was observed. No clinically significant adverse events were reported by participants. Conclusions: Treatment with non-hormonal vaginal moisturizer for 3 consecutive weeks in postmenopausal women with symptoms of genitourinary syndrome of menopause promoted improvements in vaginal hydration, showing a clinically adequate profile of efficacy and safety, in addition to a satisfactory degree of acceptability