drugset / Trial / NCT02571127

Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.

NCT02571127 ↗

Phase 4 Unknown 46 enrolled Farmoquimica S.A.
NaSingle-groupOpen-labelTreatment

Summary

Primary: Evaluation of improved vaginal moisture in postmenopausal women. Secondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation of the decrease in vaginal pH, assessment of Sexual Function Index female (FSFI), evaluation of adherence to study treatment by patient diary, assessing the acceptability of the product and subjective assessment of the patient as the itching and stinging / burning, beyond the safety assessment.

Timeline

Start
2015-10
Primary completion
2016-02
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Hidra1 Unknown — Other