Overview

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

Status:
Completed
Trial end date:
2020-09-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ospedale Policlinico San Martino
Criteria
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