Italfarmaco SA

The latest data on the prevalence of nausea in pregnancy in Switzerland is dated 2015 but has been hypothesised that the recent introduction on the market of new drugs against this symptom could modify its epidemiology. For this reason, we have planned the present survey, calculating an adequate sample size of Swiss pregnant women (the population of interest) and, according to a cross-sectional design, planning the collection of response variables with the aim of estimating the prevalence of burden and nausea and vomiting in pregnancy

Randomized, double-blind, placebo-controlled multicentre study, with parallel groups, to determine the efficacy and safety of a new low-concentration estriol formulation (ITFE-2026 0.005%) for application by vaginal route in the treatment of postmenopausal vaginal atrophy.
Primary objective:
• To evaluate the efficacy of 0.005% Estriol vaginal gel by evaluation of the change in the maturation value of the vaginal epithelium (MV) after 12 weeks of treatment.
Secondary objectives:
To determine the variation of the vaginal pH, as well as symptoms and signs suggestive of vaginal atrophy after 12 weeks of treatment.
To study the variation of the MV, pH and symptoms and signs suggestive of vaginal atrophy after an initial observation period of 3 weeks.
To evaluate the safety of 0.005% Estriol vaginal gel
To evaluate the acceptability of 0.005% Estriol vaginal gel