TITLE:
A controlled, randomized, open label study in postmenopausal women to assess the safety and the efficacy of a vaginal moisturizer: An instrumental approach
AUTHORS:
A. Sparavigna, B. Tenconi, I. De Ponti, A. Bulgheroni, F. Scarci
KEYWORDS:
Vaginal Atrophy; Vaginal Dryness; Menopause; Hygrometry
JOURNAL NAME:
Open Journal of Obstetrics and Gynecology,
Vol.3 No.4,
May
23,
2013
ABSTRACT: 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