NCT04560283

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

Randomized Clinical Trial to Assess the Efficacy and Safety of HYDEAL-D® Application in Promoting the Restoration of Sexual Function in the Postpartum Period

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Ospedale Policlinico San Martino · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vagina; Anomaly
• Puerperium; Disease
• Sexual Dysfunction

Interventions

Type	Name	Description
DRUG	Vaginal gel HYALOGYN®	Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks
BEHAVIORAL	Expectant management	Expectant management for 12 consecutive weeks

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-05-01
• Completion: 2020-09-01
• First posted: 2020-09-23
• Last updated: 2023-01-18

Locations

1 site across 1 country: Italy