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

Ospedale Policlinico San Martino

Status and phase

Completed

Phase 4

Conditions

Sexual Dysfunction

Puerperium; Disease

Vagina; Anomaly

Treatments

Drug: Vaginal gel HYALOGYN®

Behavioral: Expectant management

Study type

Interventional

Funder types

Other

Identifiers

NCT04560283

HYDEAL-D-1-2016

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Women from 18 to 40 years old;
Women in the puerperium period (after vaginal delivery or cesarean section);
Women that are breast-feeding, that are not breast-feeding or that are breast-feeding partially;

Exclusion criteria

Allergy to hyaluronic acid gel;
Women non-Italian speaking;
Women with signs of vaginal infection;
Women with a history of cancer of any site with recent genital bleeding of unknown origin; and patients with acute hepatopathy, embolic disorders, severe primary disease of kidney;
Women who are attending or have attended other clinical trials within previous two weeks;
Women with mental disorder and no insight