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CompletedNCT04560283HYDEAL-DUpdated Jan 18, 2023

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

A Phase 4 interventional study of Vaginal gel HYALOGYN® and Expectant management in Vagina; Anomaly, Puerperium; Disease and Sexual Dysfunction, sponsored by Ospedale Policlinico San Martino. Completed at 1 site in Italy. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-18.

Primary conditionCongenital Abnormalities(the registry's first term)UnverifiedIs this wrong?Congenital Abnormalities is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Ospedale Policlinico San Martino · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled Sep 2016, registered Sep 2020).
Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

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.

02

Conditions studied

  • Vagina; Anomaly
  • Puerperium; Disease
  • Sexual Dysfunction

Keywords

  • Puerperium
03

In context

Congenital Abnormalities Unverified

781 studies on the registry are indexed under Congenital Abnormalities; 77 are open to participants now.

This study's enrollment of 25 is below the median of 40 across 466 interventional studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

Ospedale Policlinico San Martino is the lead sponsor of 30 studies on the registry; 11 are open to participants now.

Compared within Congenital Abnormalities, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Experimental group receiving HYALOGYN®

    Drug: Vaginal gel HYALOGYN®

  • Placebo comparator
    Control group undergoing expectant management

    Behavioral: Expectant management

Interventions

  • DrugVaginal gel HYALOGYN®

    Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks

  • BehavioralExpectant management

    Expectant management for 12 consecutive weeks

06

What researchers measure

Primary outcomes

  1. Evaluation of sexual function by FSFI

    Time frame: At baseline; 12 weeks

07

Study locations

1 site
  • Ospedale Policlinico San Martino
    Genova, Italy
08

References and documents

Publications

  • 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. PubMed 34477473 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2016 to primary completion in May 2020, 44 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2020
First posted
Sep 23, 2020
StartActual
Sep 1, 2016
Primary completionActual
May 1, 2020
CompletionActual
Sep 1, 2020
Last update
Jan 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04560283
Lead sponsor
Ospedale Policlinico San Martino
Responsible party
Fabio Barra (Principal Investigator, Ospedale Policlinico San Martino) — Principal investigator
First posted
Sep 23, 2020
Start date
Sep 1, 2016
Primary completion
May 1, 2020
Completion
Sep 1, 2020
Last update
Jan 18, 2023

Study contacts

Fabio Barra, MD
principal investigator · Ospedale San Martino

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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