Back to resultsHYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period (HYDEAL-D)
Primary Purpose
Vagina; Anomaly, Puerperium; Disease, Sexual Dysfunction
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Vaginal gel HYALOGYN®
Expectant management
Sponsored by
About this trial
This is an interventional treatment trial for Vagina; Anomaly focused on measuring Puerperium
Eligibility Criteria
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
Sites / Locations
- Ospedale Policlinico San Martino
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group receiving HYALOGYN®
Control group undergoing expectant management
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of sexual function by FSFI
Secondary Outcome Measures
Full Information
NCT ID
NCT04560283
First Posted
September 12, 2020
Last Updated
January 15, 2023
Sponsor
Ospedale Policlinico San Martino
1. Study Identification
Unique Protocol Identification Number
NCT04560283
Brief Title
HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Policlinico San Martino
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vagina; Anomaly, Puerperium; Disease, Sexual Dysfunction
Keywords
Puerperium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group receiving HYALOGYN®
Arm Type
Experimental
Arm Title
Control group undergoing expectant management
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Vaginal gel HYALOGYN®
Intervention Description
Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks
Intervention Type
Behavioral
Intervention Name(s)
Expectant management
Intervention Description
Expectant management for 12 consecutive weeks
Primary Outcome Measure Information:
Title
Evaluation of sexual function by FSFI
Time Frame
At baseline; 12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Barra, MD
Organizational Affiliation
Ospedale San Martino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Policlinico San Martino
City
Genova
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34477473
Citation
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.
Results Reference
result
Learn more about this trial
HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period
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