Efficacy and safety of a new vaginal gel for the treatment of symptoms associated with vulvovaginal atrophy in postmenopausal women: A double-blind randomized placebo-controlled study.

作者: Rossella E. Nappi , Francesco De Seta , Salvatore Caruso , Giovanni Di Lorenzo , Federico Romano

DOI: 10.1016/J.MATURITAS.2021.03.002

关键词: Vaginal PainInternal medicineTolerabilitySexual functionRandomized controlled trialMedicineMenopausePlacebo-controlled studyClinical trialPlacebo

摘要: Abstract Objective The aim of the present randomized placebo-controlled single-center study was to assess efficacy and safety a new vaginal gel (Meclon Idra - Alfasigma) in treatment vulvovaginal atrophy (VVA). is composed sea buckthorn (Hippophae rhamnoides) oil, aloe vera, 18β-glycyrrhetic acid, hyaluronic acid glycogen. assessed whether can reduce VVA symptoms (vaginal dryness, itching, burning sensation) improve sexual function postmenopausal women over 12 weeks. Study Design Postmenopausal (n° = 60) reporting were recruited 1:1 ratio or placebo. Active placebo applied for 14 days then twice week 90 consecutive days. Main outcome measure Vaginal Health Index (VHI), including pH, used changes objective signs, whereas self-reported Female Sexual Function (FSFI) investigate function. Results Meclon effective reducing pain, dyspareunia with VHI showing significant improvement at day (P Conclusions clinical trial demonstrated efficacy, tolerability 12-week associated VVA. Based on this trial, seems be valid choice as single, local agent relieving improving function, have good compliance. This registered prospectively Clinical Trials Registry – India, number CTRI/2019/05/01911.

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