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

Ospedale Policlinico San Martino25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vagina; Anomaly Puerperium; Disease Sexual Dysfunction

Interventions

Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks

Expectant managementBEHAVIORAL

Expectant management for 12 consecutive weeks

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ospedale Policlinico San Martino

Genova, Italy

Outcomes

Primary Outcomes

Evaluation of sexual function by FSFI

Time frame: At baseline; 12 weeks

Data from ClinicalTrials.gov

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