Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.
Status:
Completed
Trial end date:
2009-02-23
Target enrollment:
Participant gender:
Summary
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