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

NCT04560283 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-01-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Ospedale Policlinico San Martino

    lead OTHER

Principal Investigators

  • Fabio Barra, MD · Ospedale San Martino

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2020-05-01
Completion
2020-09-01

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04560283 on ClinicalTrials.gov