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Completed

NCT Number: NCT04560283

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

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.

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Key information

Conditions

Vagina; Anomaly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Genital Diseases Pregnancy Complications Puerperal Disorders Puerperium; Disease Sexual Dysfunction Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale Policlinico San Martino

Genova, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal gel HYALOGYN®

Drug

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

Expectant management

Behavioral

Expectant management for 12 consecutive weeks

Primary outcomes

  1. Evaluation of sexual function by FSFI

    Time frame: At baseline; 12 weeks

Sponsors and collaborators

Lead sponsor

Ospedale Policlinico San Martino

Other

Registry information

Official study 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

Acronym: HYDEAL-D

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2020
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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