Vaginal Dryness Clinical Trial
Official title:
Medical Device Study to Investigate the Efficacy and Tolerability of Vagisan® Moisturising Cream vs. Gynomunal® Vaginal Gel in a 2-period Changeover Design in n=120 Patients With Vaginal Dryness Who Cannot or do Not Wish to Use Oestrogens
Vulvovaginal irritation due to dryness is a frequent complaint among post- and some
premenopausal women. International guidelines recommend non-hormonal products as first line
therapy.
Efficacy and safety of the medical device Vagisan® Moisturising Cream (VMC), a non-hormonal
vaginal cream for the treatment of vulvovaginal dryness and Gynomunal Vaginal Gel (GVG), a
non-hormonal gel should be compared in a 12-week multicentre, open-label, randomised,
two-period cross-over phase III trial. The hypothesis was that VMC is non-inferior to GVG.
The primary endpoint was the sum of subjective symptoms of vulvovaginal atrophy (VVA) added
up over each treatment period. Furthermore, objective symptoms of VVA and adverse effects
were planned to be assessed. 120 women should be randomly allocated to either of the two
treatments, each given over a period of 4 weeks.
The purpose of the study was to test the non-inferiority of the medical device Vagisan®
Moisturising Cream (VMC) in comparison to Gynomunal® vaginal gel (GVG) in 6 centres in 120
women who suffered from "vaginal dryness". The main objective criterion was to compare the
sum of 4 subjective symptoms of "vaginal dryness" measured daily over a period of 28 days.
VMC should be applied daily, while GVG had to be administered daily during the first week and
twice weekly thereafter.
The main objective parameter for efficacy analysis was the sum of the subjective symptoms of
vaginal dryness (feeling of dryness, itching, burning sensation and pain) before, during
(patient diaries) and after the 28-day therapy period.
The per-protocol analysis and of the intent-to-treat analysis should prove non-inferiority of
VMC compared to GVG, despite a possible carry-over effect to the detriment of VMC. To avoid
the problem of any possible carry-over effect the analysis of the first period was chosen for
the primary comparison of both products.
Furthermore, objective symptoms of vaginal dryness detected via colposcopy, the vaginal
secretion's pH, the efficacy assessment by the patients and the treating doctor and patients'
questionnaires with regard to the product characteristics of the medical devices should be
evaluated.
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