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

Sexual Dysfunction Clinical Trial

— HYDEAL-D  

Official title:

Randomized Clinical Trial to Assess the Efficacy and Safety of HYDEAL-D® Application in Promoting the Restoration of Sexual Function in the Postpartum Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560283
• Other study ID #: HYDEAL-D-1-2016
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: September 1, 2020

Study information

• Verified date: January 2023
• Source: Ospedale Policlinico San Martino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Puerperal Disorders
• Puerperium; Disease
• Sexual Dysfunction
• Vagina; Anomaly

Intervention

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

Behavioral:
• Expectant management
Expectant management for 12 consecutive weeks

Locations

Country	Name	City	State
Italy	Ospedale Policlinico San Martino	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

References & 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 prospect — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of sexual function by FSFI		At baseline; 12 weeks