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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04560283
Recruitment Status : Completed
First Posted : September 23, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Fabio Barra, Ospedale Policlinico San Martino

Study Description
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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
Vagina; Anomaly Puerperium; Disease Sexual Dysfunction Drug: Vaginal gel HYALOGYN® Behavioral: Expectant management Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 1, 2016
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : September 1, 2020
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Evaluation of sexual function by FSFI [ Time Frame: At baseline; 12 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560283


Locations
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Italy
Ospedale Policlinico San Martino
Genova, Italy
Sponsors and Collaborators
Ospedale Policlinico San Martino
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fabio Barra, Medical Doctor, Ospedale Policlinico San Martino
ClinicalTrials.gov Identifier: NCT04560283    
Other Study ID Numbers: HYDEAL-D-1-2016
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Ospedale Policlinico San Martino:
Puerperium
Additional relevant MeSH terms:
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Puerperal Disorders
Pregnancy Complications