Vulvo Vaginal AtrophyNCT06922136
Evaluation of the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in Postmenopausal Breast Cancer Survivors
A study testing Hyalo Gyn Vaginal Gel in people with Vulvo Vaginal Atrophy, run by Fidia Farmaceutici s.p.a. at 7 sites in Italy.
Trial summary
Eligible patients will be randomized to treatment with Hyalo Gyn® gel or placebo, at the dose regimen of 1 application deeply in the vagina every 3 days (i.e. an application is followed by 2 days without application), up to a total of 12 consecutive weeks. After 12 weeks (i.e. Read more about this study
- Who is it for?
- Ages 25 to 80 years, women only
- Conditions the study is for
- Vulvo Vaginal Atrophy
- What is being tested?
- Hyalo Gyn Vaginal Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 7 sitesItaly
- Study dates
- 1 Aug 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to beginning specific protocol procedures;
- Women between 25 and 80 years of age (inclusive);
- Women with intention or willingness to have sex;
- Patients with a history of breast cancer who had completed primary cancer treatment (surgery, non-endocrine chemotherapy, or radiation therapy) 3-60 months prior to enrolment;
- Patient receiving endocrine therapy (an AI or tamoxifen or a GnRH analogue) as a breast cancer treatment in the adjuvant setting for a minimum of 3 months. The therapy program must cover the entire duration of the study (24 weeks);
- Life expectancy of at least 12 months;
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- Postmenopausal status defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/ml or 6 weeks' postsurgical bilateral oophorectomy with or without hysterectomy;
- Vulvovaginal dryness assessed as moderate to severe. A moderate and severe symptom (i.e. a score of 2 = moderate or 3 = severe) will be considered if the symptoms are present and could be bothersome and could interfere with the normal patient activity;
- Vaginal Health Index ≤15;
- Vaginal pH ≥5;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1;
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures;
- Patients legally able to give written informed consent to the trial (signed and dated by the participant) and able to understand study procedures and protocol requirements.
Who cannot join
- Stage IIIB-IV breast cancer;
- Treatment with any other current anti-tumoral therapy besides an AI or tamoxifen or a GnRH analogue;
- Prior history of other malignancy other to breast cancer within 5 years of study entry, with the exception of non-melanoma skin cancer or carcinoma in-situ of the uterine cervix adequately treated;
- Postmenopausal uterine bleeding and/or vaginal bleeding of unknown aetiology;
- Patients with endometrial thickness equal to or greater than 4 mm for patientson AI or GnRH analogue, or equal to or greater than 9 mm for patients on tamoxifen, measured by transvaginal ultrasound;
- Patients who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study;
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- Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV), confirmed with a vaginal swab;
- Patients with a history of vulvovaginal contact allergy or with a diagnosis of vulvovaginal lichen;
- Positive history of hypersensitivity to hyaluronic acid (HA) or to any component of the medical device;
- Use of any hormone, or any products with phytoestrogenic activity (for instance resveratrol, flax seeds, hops, isoflavones as red clover and soy) for the treatment of menopausal symptoms in the previous month (cimicifuga extract and pollen are allowed);
- Known human immunodeficiency virus infection;
- Other severe acute or chronic medical condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with investigation participation or product administration and investigation's procedures, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this investigation;
- Previous investigational treatment for any condition or participation in any clinical trial in the previous month before inclusion date
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
Policlinico SantOrsola Malpighi
Bologna, BO, 40138
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, FI, 50134
Istituto Europeo di Oncologia
Milan, 20141
Azienda Ospedaliera-Universitaria UOC Clinica Ginecologica e Ostetrica dell'Università
Padova, PD, 35128
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, 00168
AO Ordine Mauriziano di Torino, Ospedale Umberto I
Torino, TO, 10128
About this study
Official title: A Prospective, Randomized, Controlled, 2-arms, Double-blind, Multicentre Clinical Investigation to Evaluate the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in the Management of Vulvovaginal Atrophy in Postmenopausal Breast Cancer Survivors
Eligible patients will be randomized to treatment with Hyalo Gyn® gel or placebo, at the dose regimen of 1 application deeply in the vagina every 3 days (i.e. an application is followed by 2 days without application), up to a total of 12 consecutive weeks.
After 12 weeks (i.e. at Visit 3), the following rules will apply for the second 12- week phase of the study:
- In case of resolution of the symptom (the dryness single score is equal to zero), the patient will suspend treatment and will undergo follow-up visits;
- In case of the single score is reduced but still greater than zero: the subject will receive Hyalo Gyn® open-label.
- In case the dryness gets worse the subject can choose whether receive Hyalo Gyn® gel open-label or undergo the follow-up visits. Patients will be allowed to use only water-based lubricants, not containing HA, hormones, or isoflavones, if necessary, only when engaging in sexual activity and specifying the reason for its use (multiple choice answer). The number of lubricant applications, as well as the frequency of the sexual activity, will be recorded weekly in the diary by the patient.
Read the detailed description
This will be a prospective, randomized, controlled, 2-arms, placebo-controlled, double-blind, multicentre clinical investigation. Patients with good compliance and who are voluntary to sign the informed consent will be enrolled in a period time of approximately 6 months. The screened and eligible patients will be randomly assigned in one of the two groups: Group A will receive Hyalo Gyn® and Group B will receive Placebo. Neither the Investigator nor the Patient will be aware of the assigned treatment.
Subjects of both groups will start the treatment with 1 application of Hyalo Gyn® gel or placebo gel, deeply in the vagina every 3 days (i.e. an application is followed by 2 days without application) up to a total of 12 consecutive weeks.
After 12 weeks (i.e. at Visit 3), according to the status of dryness symptom, measured with the VRS dryness score from baseline to 12 weeks, patients will undergo different procedures for the second phase of the study as reported in the brief summary.
Visits at the investigational site will be performed at screening/baseline (V0, Week 0) and every 4 weeks, alternated to telephone contacts by the clinician (V1, Week 4; T1, Week 6; V2, Week 8; T2, Week 10; V3, Week 12) up to the end of the first 12-week phase of the study. Two phone follow-up visits will be performed at Week 16 (T3) and Week 20 (T4), followed by a visit at the investigational site at the end of the second 12-week phase of the study (V4, Week 24). Visit 4 (Week 24) will represent the end of study visit. In case of premature withdrawal from the investigation for whatever reason an "Early termination Visit" will be performed, which will include all assessments foreseen for the final visit (Visit 4, Week 24 ± 5 days).
- Conditions
- Vulvo Vaginal Atrophy
- Being tested
- Hyalo Gyn Vaginal Gel, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyalo Gyn Vaginal GelDevice
Hyalo Gyn® is uniquely formulated with Hydeal-D®, a proprietary HA derivative component manufactured by Fidia Farmaceutici S.p.A.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A: Hyalo Gyn® Gel | Experimental | Hyalo Gyn® vaginal gel is formulated with Hydeal-D®, a proprietary HA derivative component Receives: Device: Hyalo Gyn Vaginal Gel |
| Group B: Placebo | Placebo comparator | Matched plecebo A Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the performance of Hyalo Gyn® vaginal gel in the improvement of patient's perception of vulvovaginal dryness associated with vulvovaginal atrophy, after 12 weeks of treatment, compared to placebo.
The primary performance endpoint of the investigation will be the change in the vulvovaginal dryness associated with vulvovaginal atrophy, evaluated as the proportion of subjects having a reduction ≥2 points in the Verbal Rating Scale (VRS) dryness score from baseline to 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. The vulvovaginal symptom associated with vulvovaginal atrophy (dryness) will be reported on a four-point scale (0 = absent, 1 = mild, 2 = moderate, 3= severe).
Measured: after 12 weeks of treatment
Secondary outcomes (9)
Change from baseline in patient's perception of dryness, irritation/itching, soreness, dysuria, and dyspareunia vulvovaginal symptoms single scores associated with vulvovaginal atrophy
Change from baseline in the vulvovaginal symptoms associated with vulvovaginal atrophy, evaluated by measuring the VRS single score at baseline and at 4, 6, 8, 10, and 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. Each vulvovaginal symptom associated with vulvovaginal atrophy (dryness, irritation/itching, soreness, dysuria, dyspareunia) will be reported on a four-point scale (0 = absent, 1= mild, 2 = moderate, 3 = severe);
Measured: After 4, 6, 8, 10, and 12 weeks of treatment from baseline (V0)
Change from baseline in patient's perception of vulvovaginal symptoms global score associated with vulvovaginal atrophy;
Change from baseline in the vulvovaginal symptoms associated with vulvovaginal atrophy, evaluated by measuring the VRS global score at baseline and at 4, 6, 8, 10, and 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. Each vulvovaginal symptom associated with vulvovaginal atrophy (dryness, irritation/itching, soreness, dysuria, dyspareunia) will be reported on a four-point scale and the sum of every single score will be calculated (0 = absent,
1= mild, 2 = moderate, 3 = severe);
Measured: After 4, 6, 8, 10, and 12 weeks of treatment from baseline (V0)
Change from baseline of sexual function through Female Sexual Function Index (FSFI) questionnaire
Change from baseline in the sexual function, evaluated with the questionnaire FSFI at 4, 8, and 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. The FSFI questionnaire consists of 19 items (six subscales: desire, arousal, lubrication, orgasm, satisfaction, and pain). Total scores range from 2 to 36, with higher scores reflecting better sexual function (cut-off value = 26.5).
Measured: After 4, 8 and 12 weeks of treatment from baseline (V0)
Change from baseline of sexual function through Female Sexual Distress Scale-Revised (FSDS-R) questionnaire
Change from baseline in the sexual distress, evaluated with the FSDS-R at 4, 8, and 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. The FSDS-R questionnaire consists of 13 items and items are scored on a five-point rating scale (0 = never; 1 = rarely; 2 = occasionally; 3 = frequently; 4 = always). Total score ranges from 0 to 52, with higher scores indicating greater sexual distress (cut-off value = 11);
Measured: After 4, 8 and 12 weeks of treatment from baseline (V0)
Change from baseline of Vaginal Health Index (VHI);
Change from baseline in vaginal signs associated with vulvovaginal atrophy, evaluated by measuring the average score of VHI at baseline and at 4, 8, and 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. The VHI will be calculated assigning a score between 1 to 5 for vaginal moisture, vaginal fluid volume, vaginal elasticity, vaginal pH, and vaginal epithelial integrity on a scale of 1 to 5. The assigned score will vary from 5 to 25. The lower the score, the greater the atrophy (cut-off value = 15).
Measured: After 4, 8 and 12 weeks of treatment from baseline (V0),
Change from baseline of the objective genitourinary atrophy signs (Vaginal Maturation Index (VMI, only after 12 weeks);
Change from baseline of the objective genitourinary atrophy sign VMI, evaluated at baseline and at 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. VMI quantifies the percentages of parabasal, intermediate, and superficial cells by using the formula: VMI = [1(% superficial cells)] + [0.6(% intermediate cells)] + [0.2(% parabasal cells)] (0%-49%, low stimulation of the vaginal epithelium; 50%-64%, moderate stimulation of the vaginal epithelium; 65%-100%, high stimulation of the vaginal epithelium).
Measured: After 4, 8 and 12 weeks of treatment from baseline (V0
Change from baseline of the objective genitourinary atrophy sign, vaginal pH
Change from baseline of the objective genitourinary atrophy sign vaginal pH, evaluated by measuring values of vaginal pH at baseline and at 4, 8, and 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. The pH values will be grouped in a 4-point scale and scored respectively: pH < 5 (0), 5-5.49 (1), 5.5- 6.49 (2), and more than 6.49 (3)
Measured: After 4, 6, 8, 10, and 12 weeks of treatment from baseline (V0)
Evaluation of Patient's global assessment (PTGA) of overall satisfaction
PTGA of overall satisfaction, evaluated at 4, 8, and after 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. The patient will be requested to score the overall satisfaction of the treatment on a four-grade scale: 0 = dissatisfied or very dissatisfied, 1 = moderately satisfied or satisfied, 2 = very satisfied, and 3 = greatly satisfied
Measured: After 4, 8, and 12 weeks of treatment from baseline (V0)
Evaluation of the safety and tolerability of Hyalo Gyn® vaginal gel compared to placebo during the entire course of the study
Safety of the treatment, evaluated at 4, 6, 8, 10, and 12 weeks of treatment by tracking the number of patient withdrawals and collecting the local and general adverse events that occur during the study
Measured: After 4, 6, 8, 10, and 12 weeks of treatment from baseline (V0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Aug 2024
- Primary completion30 Jan 2026
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvo Vaginal AtrophyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, 2-arms, placebo-controlled, double-blind, multicentre clinical investigation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922136
- Sponsor's protocol ID
- QQ53-21-01
- Status last verified
- Feb 2026
- First submitted
- 17 Mar 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, 2-arms, Double-blind, Multicentre Clinical Investigation to Evaluate the Performance and Safety of Hyalo Gyn® Gel Compared to Placebo in the Management of Vulvovaginal Atrophy in Postmenopausal Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06922136
- Acronym / sponsor ID
- QQ53-21-01
- Conditions
- Vulvo Vaginal Atrophy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- May 2026 (estimated)
- First posted
- 10 Apr 2025 (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.
Eligible patients will be randomized to treatment with Hyalo Gyn® gel or placebo, at the dose regimen of 1 application deeply in the vagina every 3 days (i.e. an application is followed by 2 days without application), up to a total of 12 consecutive weeks.
After 12 weeks (i.e. at Visit 3), the following rules will apply for the second 12- week phase of the study:
- In case of resolution of the symptom (the dryness single score is equal to zero), the patient will suspend treatment and will undergo follow-up visits;
- In case of the single score is reduced but still greater than zero: the subject will receive Hyalo Gyn® open-label.
- In case the dryness gets worse the subject can choose whether receive Hyalo Gyn® gel open-label or undergo the follow-up visits. Patients will be allowed to use only water-based lubricants, not containing HA, hormones, or isoflavones, if necessary, only when engaging in sexual activity and specifying the reason for its use (multiple choice answer). The number of lubricant applications, as well as the frequency of the sexual activity, will be recorded weekly in the diary by the patient.
Detailed description
This will be a prospective, randomized, controlled, 2-arms, placebo-controlled, double-blind, multicentre clinical investigation. Patients with good compliance and who are voluntary to sign the informed consent will be enrolled in a period time of approximately 6 months. The screened and eligible patients will be randomly assigned in one of the two groups: Group A will receive Hyalo Gyn® and Group B will receive Placebo. Neither the Investigator nor the Patient will be aware of the assigned treatment.
Subjects of both groups will start the treatment with 1 application of Hyalo Gyn® gel or placebo gel, deeply in the vagina every 3 days (i.e. an application is followed by 2 days without application) up to a total of 12 consecutive weeks.
After 12 weeks (i.e. at Visit 3), according to the status of dryness symptom, measured with the VRS dryness score from baseline to 12 weeks, patients will undergo different procedures for the second phase of the study as reported in the brief summary.
Visits at the investigational site will be performed at screening/baseline (V0, Week 0) and every 4 weeks, alternated to telephone contacts by the clinician (V1, Week 4; T1, Week 6; V2, Week 8; T2, Week 10; V3, Week 12) up to the end of the first 12-week phase of the study. Two phone follow-up visits will be performed at Week 16 (T3) and Week 20 (T4), followed by a visit at the investigational site at the end of the second 12-week phase of the study (V4, Week 24). Visit 4 (Week 24) will represent the end of study visit. In case of premature withdrawal from the investigation for whatever reason an "Early termination Visit" will be performed, which will include all assessments foreseen for the final visit (Visit 4, Week 24 ± 5 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, 2-arms, placebo-controlled, double-blind, multicentre clinical investigation
| Arm | Type | Receives |
|---|---|---|
| Group A: Hyalo Gyn® Gel | Experimental | Device: Hyalo Gyn Vaginal GelHyalo Gyn® vaginal gel is formulated with Hydeal-D®, a proprietary HA derivative component |
| Group B: Placebo | Placebo comparator | Other: PlaceboMatched plecebo A |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent prior to beginning specific protocol procedures;
- Women between 25 and 80 years of age (inclusive);
- Women with intention or willingness to have sex;
- Patients with a history of breast cancer who had completed primary cancer treatment (surgery, non-endocrine chemotherapy, or radiation therapy) 3-60 months prior to enrolment;
- Patient receiving endocrine therapy (an AI or tamoxifen or a GnRH analogue) as a breast cancer treatment in the adjuvant setting for a minimum of 3 months. The therapy program must cover the entire duration of the study (24 weeks);
Key exclusion criteria (13 listed)
- Stage IIIB-IV breast cancer;
- Treatment with any other current anti-tumoral therapy besides an AI or tamoxifen or a GnRH analogue;
- Prior history of other malignancy other to breast cancer within 5 years of study entry, with the exception of non-melanoma skin cancer or carcinoma in-situ of the uterine cervix adequately treated;
- Postmenopausal uterine bleeding and/or vaginal bleeding of unknown aetiology;
- Patients with endometrial thickness equal to or greater than 4 mm for patientson AI or GnRH analogue, or equal to or greater than 9 mm for patients on tamoxifen, measured by transvaginal ultrasound;
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 |
|---|---|---|
| Hyalo Gyn Vaginal GelHyalo Gyn® is uniquely formulated with Hydeal-D®, a proprietary HA derivative component manufactured by Fidia Farmaceutici S.p.A. | Device | Group A: Hyalo Gyn® Gel |
| PlaceboPlacebo | Other | Group B: Placebo |
Primary outcome
Evaluation of the performance of Hyalo Gyn® vaginal gel in the improvement of patient's perception of vulvovaginal dryness associated with vulvovaginal atrophy, after 12 weeks of treatment, compared to placebo.
Time frame: after 12 weeks of treatment
The primary performance endpoint of the investigation will be the change in the vulvovaginal dryness associated with vulvovaginal atrophy, evaluated as the proportion of subjects having a reduction ≥2 points in the Verbal Rating Scale (VRS) dryness score from baseline to 12 weeks of treatment with Hyalo Gyn® gel compared to placebo. The vulvovaginal symptom associated with vulvovaginal atrophy (dryness) will be reported on a four-point scale (0 = absent, 1 = mild, 2 = moderate, 3= severe).
9 secondary outcomes
Change from baseline in patient's perception of dryness, irritation/itching, soreness, dysuria, and dyspareunia vulvovaginal symptoms single scores associated with vulvovaginal atrophy
Time frame: After 4, 6, 8, 10, and 12 weeks of treatment from baseline (V0)
Change from baseline in patient's perception of vulvovaginal symptoms global score associated with vulvovaginal atrophy;
Time frame: After 4, 6, 8, 10, and 12 weeks of treatment from baseline (V0)
Change from baseline of sexual function through Female Sexual Function Index (FSFI) questionnaire
Time frame: After 4, 8 and 12 weeks of treatment from baseline (V0)
Change from baseline of sexual function through Female Sexual Distress Scale-Revised (FSDS-R) questionnaire
Time frame: After 4, 8 and 12 weeks of treatment from baseline (V0)
Change from baseline of Vaginal Health Index (VHI);
Time frame: After 4, 8 and 12 weeks of treatment from baseline (V0),
Change from baseline of the objective genitourinary atrophy signs (Vaginal Maturation Index (VMI, only after 12 weeks);
Time frame: After 4, 8 and 12 weeks of treatment from baseline (V0
Change from baseline of the objective genitourinary atrophy sign, vaginal pH
Time frame: After 4, 6, 8, 10, and 12 weeks of treatment from baseline (V0)
Evaluation of Patient's global assessment (PTGA) of overall satisfaction
Time frame: After 4, 8, and 12 weeks of treatment from baseline (V0)
Evaluation of the safety and tolerability of Hyalo Gyn® vaginal gel compared to placebo during the entire course of the study
Time frame: After 4, 6, 8, 10, and 12 weeks of treatment from baseline (V0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyalo Gyn Vaginal Gel in people with Vulvo Vaginal Atrophy, run by Fidia Farmaceutici s.p.a. at 7 sites 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 13 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 the performance of Hyalo Gyn® vaginal gel in the improvement of patient's perception of vulvovaginal dryness associated with vulvovaginal atrophy, after 12 weeks of treatment, compared to placebo. (time frame: after 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.