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

Sponsor
Ospedale Policlinico San Martino (Other)
Overall Status
Completed
CT.gov ID
NCT04560283
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
48
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Vaginal gel HYALOGYN®
  • Behavioral: Expectant management
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group receiving HYALOGYN®

Drug: Vaginal gel HYALOGYN®
Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks
Placebo Comparator: Control group undergoing expectant management

Behavioral: Expectant management
Expectant management for 12 consecutive weeks

Outcome Measures

Primary Outcome Measures

  1. Evaluation of sexual function by FSFI [At baseline; 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale Policlinico San Martino Genova Italy

Sponsors and Collaborators

  • Ospedale Policlinico San Martino

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fabio Barra, Medical Doctor, Ospedale Policlinico San Martino
ClinicalTrials.gov Identifier:
NCT04560283
Other Study ID Numbers:
  • HYDEAL-D-1-2016
First Posted:
Sep 23, 2020
Last Update Posted:
Sep 23, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Fabio Barra, Medical Doctor, Ospedale Policlinico San Martino
Puerperium
Additional relevant MeSH terms:
Puerperal Disorders

Study Results

No Results Posted as of Sep 23, 2020