- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560283
HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period (HYDEAL-D)
Randomized Clinical Trial to Assess the Efficacy and Safety of HYDEAL-D® Application in 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Genova, Italy
- Ospedale Policlinico San Martino
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group receiving 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
|
Expectant management for 12 consecutive weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of sexual function by FSFI
Time Frame: At baseline; 12 weeks
|
At baseline; 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fabio Barra, MD, Ospedale San Martino
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYDEAL-D-1-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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