Vagina; AnomalyPhase 4HYDEAL-DNCT04560283
HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period
A Phase 4 study testing Vaginal gel HYALOGYN® and Expectant management in people with Vagina; Anomaly and Puerperium; Disease, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vagina; Anomaly, Puerperium; Disease, Sexual Dysfunction
- What is being tested?
- Vaginal gel HYALOGYN® and Expectant management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2016to 1 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Vagina; Anomaly, Puerperium; Disease, Sexual Dysfunction
- Being tested
- Vaginal gel HYALOGYN®, Expectant management
- Keywords
- Puerperium
- Medical subject headings
- Congenital Abnormalities, Puerperal Disorders, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal gel HYALOGYN®Drug
Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks
Expectant managementBehavioural
Expectant management for 12 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group receiving HYALOGYN® | Experimental | Not described Receives: Drug: Vaginal gel HYALOGYN® |
| Control group undergoing expectant management | Placebo comparator | Not described Receives: Behavioral: Expectant management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sexual function by FSFI
Measured: At baseline; 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Sep 2016
- Primary completion1 May 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vagina; AnomalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Barra, Ospedale Policlinico San Martino
- Investigators
- Fabio Barra, MD, Principal investigator, Ospedale San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560283
- Sponsor's protocol ID
- HYDEAL-D-1-2016
- Acronym
- HYDEAL-D
- Status last verified
- Jan 2023
- First submitted
- 12 Sep 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04560283
- Acronym / sponsor ID
- HYDEAL-D / HYDEAL-D-1-2016
- Conditions
- Vagina; Anomaly, Puerperium; Disease, Sexual Dysfunction
- Keywords
- Puerperium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group receiving HYALOGYN® | Experimental | Drug: Vaginal gel HYALOGYN® |
| Control group undergoing expectant management | Placebo comparator | Behavioral: Expectant management |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal gel HYALOGYN®Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks | Drug | Experimental group receiving HYALOGYN® |
| Expectant managementExpectant management for 12 consecutive weeks | Behavioural | Control group undergoing expectant management |
Primary outcome
Evaluation of sexual function by FSFI
Time frame: At baseline; 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Results publication: PubMed 34477473Gustavino 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Barra, MD principal investigator
Ospedale San Martino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaginal gel HYALOGYN® and Expectant management in people with Vagina; Anomaly and Puerperium; Disease, run by Ospedale Policlinico San Martino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sexual function by FSFI (time frame: At baseline; 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.