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

Phase 4

Completed

• Conditions: Puerperium; Disease; Sexual Dysfunction; Vagina; Anomaly
• Interventions: Drug: Vaginal gel HYALOGYN®; Behavioral: Expectant management

• Registration Number: NCT04560283
• Lead Sponsor: Ospedale Policlinico San Martino

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-09-01
• Study First Submitted: 2020-09-12
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-15
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group receiving HYALOGYN®	Vaginal gel HYALOGYN®	-
Control group undergoing expectant management	Expectant management	-

Primary Outcome Measures

Name	Time	Method
Evaluation of sexual function by FSFI	At baseline; 12 weeks

Trial Locations

Locations (1)

Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy