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

NCT04560283 | Completed Phase 4

• 1 other identifier: HYDEAL-D-1-2016
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Vagina; Anomaly; Puerperium; Disease; Sexual Dysfunction

Keywords

Puerperium

Outcome Measures

Primary Outcomes (1)

• Evaluation of sexual function by FSFI

  At baseline; 12 weeks

Study Arms (2)

Experimental group receiving HYALOGYN®

EXPERIMENTAL

Drug: Vaginal gel HYALOGYN®

Control group undergoing expectant management

PLACEBO COMPARATOR

Behavioral: Expectant management

Interventions

Vaginal gel HYALOGYN® DRUG

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

Experimental group receiving HYALOGYN®

Expectant management BEHAVIORAL

Expectant management for 12 consecutive weeks

Control group undergoing expectant management

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead

Study Sites (1)

Ospedale Policlinico San Martino

Genova, Italy

Location

Related Publications (1)

• Gustavino C, Sala P, Cusini N, Gravina B, Ronzini C, Marcolin D, Vellone VG, Paudice M, Nappi R, Costantini S, Ferrero S, Barra F. Efficacy and safety of prolonged-release hyaluronic acid derivative vaginal application in the postpartum period: a prospective randomised clinical trial. Ann Med. 2021 Dec;53(1):1589-1597. doi: 10.1080/07853890.2021.1974083.

  PMID: 34477473 RESULT

MeSH Terms

Conditions

Congenital Abnormalities; Puerperal Disorders; Sexual Dysfunction, Physiological

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Fabio Barra, MD

  Ospedale San Martino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: September 23, 2020
• Study Start: September 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

IT (1)