A controlled, randomized, open label study in postmenopausal women to assess the safety and the efficacy of a vaginal moisturizer: An instrumental approach

摘要

Background: Vulvovaginal atrophy is an inflammatory condition linked with estrogenic deficiency, as well as decreased lubrication. The study aimed at the objective measurements of vaginal moisture (RH%), in fertile women and in postmenopausal women before and during treatment with a non-estrogenic moisturizing gel. Methods: The study followed a stepwise design. Acute: 5 women with postmenopausal vaginal dryness were measured their RH% at baseline and 30 minutes after the application of a moisturizer. Fertile Controls: 20 women were measured in the follicular phase and20 inthe luteal phase. Chronic: Forty postmenopausal women with mild/moderate vaginal dryness were randomly assigned to treatment (once/day for the first week and twice/week for the following 11 weeks) or untreated control group. Primary parameter was RH%, done by means of a vaginal hygrometer manufactured and validated for the specific purpose. Secondary parameters were the evaluation of erythema and oedema, scored for severity. Results: Fertile women showed an average 93/95 RH%, independently on the cycle phase. Postmenopausal women had 49/69 RH% in absence of any treatment. A 37% increased RH% was observed 30 min after a single application. During chronic treatment, RH% measured not earlier than 2 hours after the application of the product, resulted 7.8% to 10.4% higher than baseline (p < 0.05). Erythema improved accordingly. Conclusions: The vaginal moisturizer proved to be safe and to increase vaginal moisture short after treatment initiation;moreover, its effect proved to be long lasting.