Efficacy, tolerability and safety of a new medical device, Monurelle Biogel® vaginal gel, in the treatment of vaginal dryness: a randomized clinical trial in women of reproductive age

Abstract Objective To prove the efficacy, tolerability and safety of Monurelle Biogel ® (ZP-025) vaginal gel, which contains a purified, dialyzed, lyophilized bovine colostrum, in women of reproductive age suffering from vaginal dryness. Design Randomized clinical trial (RCT) (Z7213M01). Setting Five University Gynaecological Units. Patients Ninety-five subjects were allocated at random to receive either ZP-025 ( n  = 48) for about 23 intermenstrual days (1 or 2 times/daily intra-vaginally) or no treatment (lubricants on demand were allowed). Main outcome measures Change of Verbal Rating Scale (VRS) total and single score for vaginal symptoms, Vaginal Health Index (VHI) score, Female Sexual Function index (FSFI) and Female Sexual Distress Scale-revised (FSDS-R) scores. Results A total number of 85 subjects was evaluable for primary analyses. Symptoms (VRS) of vaginal discomfort improved significantly already after 11 days, as compared to the control arm ( p p p p p  = 0.01)]. Women reported a compliance rate of 100% for one ZP-025 application/day. Local tolerability of ZP-025 was excellent or good in 82.9% of the subjects. Conclusions The present multicentre RCT supports the use of Monurelle Biogel ® in women of reproductive age reporting symptoms of vaginal dryness. A positive impact on vaginal health and sexual function was also evident.