Phase 3CompletedAge-related condition
Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.
Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicentre Study, to Determine Efficacy and Safety of a Low Concentration Estriol (ITFE-2026 0.005%) by Vaginal Route in the Treatment of Postmenopausal Vaginal Atrophy.
- Sponsor
- Italfarmaco S.A (Industry)
- Enrollment
- 167 enrolled
- Conditions
- Vaginal Atrophy
- Interventions
- Estriol; Placebo
- Ages
- children, adults, older adults
- Registry
- NCT04574999
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Change From Baseline to Week 12 in Maturation Value (MV) After 12 Weeks of Treatment
History
Results first posted
Last registry update
Registered
Primary completion
Started