Menopause Clinical Trial
Official title:
Humectant Activity of a New Formulation of Gynomunal® Vaginalgel: Crossover Test Use Versus Previous Formula
Aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of Gynomunal® vaginalgel in menopausal women (menopause since at least 2 years) with referred vaginal dryness
Randomized, controlled, crossover clinical study; the subjects will use both formulations
with an interval of 1 week (wash out period), in reversed sequence according to the
treatment arm assigned at each subject during the basal visit.
Both tested products will be applied in the vagina, using the dedicated applicator, once a
day, preferably at bedtime. To investigate the activity of the products under study, 4
visits will be performed: a baseline visit (T0), a visit at the end of the first
week-treatment (T1), a visit at the end of the wash out period (T2) and a final visit at the
end of the second week-treatment (T3).
Volunteers will be asked to follow their normal life and sexual habits, except for not
having sexual intercourse 48 hours prior to each examination.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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