drugset / Trial / NCT04560283

HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period

NCT04560283 ↗

Phase 4 Completed 25 enrolled Ospedale Policlinico San Martino
RandomizedParallel-groupOpen-labelTreatment

Summary

During postpartum and lactation, vaginal epithelium tends to have an impaired degree of hydration and lubrication. This may lead to vaginal dryness, burning sensation dyspareunia or itching, which negatively affect the sexual function of puerperal women. This study aimed to evaluate the efficacy of HYDEAL-D® vaginal gel (HYALOGYN®, Fidia Farmaceutici, Abano Terme, Italy) application on promoting the restoration of sexual function in the postpartum period.

Timeline

Start
2016-09-01
Primary completion
2020-05-01
Completion
2020-09-01

Outcome

Met primary endpoint

paper FSFI) total score (+15.1 ± 11.9 vs +6.5 ± 8.9, p < 0.001) PMID 34477473 ↗

paper the results of our study demonstrated that hyaluronic acid derivative vaginal gel (Hydeal-D) was able to improve sexual function PMID 34477473 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject HYALOGYN Other / unclassified 2 % Other