Vulvovaginal AtrophyNCT04355403
Performance and Safety of Hyalo Gyn Gel on the Treatment of Vaginal Atrophy in Postmenopausal Women
A study testing Hyalo Gyn gel in prefilled applicators in people with Vulvovaginal Atrophy, run by Fidia Farmaceutici s.p.a. at 2 sites in Slovakia.
Trial summary
This clinical investigation evaluates the performance and safety of Hyalo Gyn, a hyaluronic acid derivative based vaginal gel for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Hyalo Gyn gel in prefilled applicators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSlovakia
- Study dates
- 5 Feb 2019to 28 Jun 2019
- Phase
- Interventional
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels >40 IU/L), both natural postmenopause or medical postmenopause (breast cancer patients undergoing a concurrent treatment with aromatase inhibitors or tamoxifen).
- Women between 18 and 75 years of age.
- Vaginal pH ≥5.
- Vulvovaginal atrophy with VHI < 15.
- At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity.
- Women with active sex life.
- Patients who give written informed consent to participate in the trial.
Who cannot join
- Treatment with another investigational product within the previous 3 months.
- Previous participation in any clinical study with Hydeal-D based investigational products.
- Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
- Patients in previous treatment with either oral or topical hormonal products within 1 month.
- Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); history of vulvovaginal contact allergy or with a diagnose of vulvovaginal lichen.
- Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
- Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
- Any condition in the investigator's opinion not suitable for the inclusion of the patient.
Trial locations and contacts
2 sites in 1 country.
Slovakia2 sites
Gynkomed s.r.o.
Bratislava, 83107
ULMUS, s r.o.
Hlohovec, 920 01
About this study
Official title: A Prospective, Randomized, Controlled, Open-label Clinical Investigation to Assess the Performance and Safety of Hyalo Gyn Gel Prefilled Applicators on the Treatment of Vaginal Atrophy in Postmenopausal Women
This clinical investigation evaluates the performance and safety of Hyalo Gyn, a hyaluronic acid derivative based vaginal gel for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Hyalo Gyn gel in prefilled applicators
- Keywords
- Hyaluronic Acid, Post-menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyalo Gyn gel in prefilled applicatorsDevice
One vaginal application of Hyalo Gyn gel every 3 days to a total of 12 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hyalo Gyn gel | Experimental | Vaginal application of Hyalo Gyn gel in prefilled applicators Receives: Device: Hyalo Gyn gel in prefilled applicators |
| No treatment | No intervention | No treatment application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of patient's perception of vulvovaginal dryness
Change of patient's perception of vulvovaginal dryness associated with vulvovaginal atrophy in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. The vulvovaginal dryness was reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe).
Measured: From baseline to 12 weeks of treatment
Secondary outcomes (11)
Change of patient's perception of vulvovaginal dryness
Change of patient's perception of vulvovaginal dryness associated with vulvovaginal atrophy in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. The vulvovaginal dryness was reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe).
Measured: From baseline to 4 weeks of treatment
Change of patient's perception of vulvovaginal symptoms
Change of patient's perception of symptoms associated with vulvovaginal atrophy in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. Each symptom (dryness, irritation/itching, soreness, dysuria, dyspareunia) will be reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe)
Measured: From baseline to 4 and 12 weeks of treatment
Change of the average score of Vaginal Health Index (VHI)
Change of VHI in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. VHI will be calculated on the basis of vaginal elasticity, vaginal fluid volume, vaginal pH, vaginal mucosa epithelial integrity, and vaginal moisture on a scale ranging from 1 (poorest) to 5 (best). VHI assigned score is the sum of subscores and ranges from 5 to 25. A lower score corresponds to a greater atrophy.
Measured: From baseline to 4 and 12 weeks of treatment
Change of vaginal pH
Change of vaginal pH in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. The pH values are grouped on a four-point scale and scored respectively: pH lower than 5 = 0; pH between 5 and 5.49 = 1; pH between 5.5 and 6.49 = 2; pH higher than 6.49 =3.
Measured: From baseline to 4 and 12 weeks of treatment
Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)
Improvement of sexual function in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. Female Sexual Function Index (FSFI) questionnaire consists of six domains - desire (two items), arousal (four items), lubrication (four items), orgasm (three items), satisfaction (three items), and pain (three items) - answered on a five-point Likert scale (0, no sexual activity; 1, never/very low; 5, always/very high). A score is calculated for each of the six domains, and the total score is obtained by summing all of the items. Total score ranges from 2 to 36. A lower score corresponds to a greater sexual dysfunction.
Measured: From baseline to 4 and 12 weeks of treatment
Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)
Improvement of sexual function in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. Female Sexual Distress Scale-Revised (FSDS-R) questionnaire consists of 13 items scored on a five-point scale (0, never; 1, rarely; 2, occasionally; 2, frequently; 4, always). The total score is obtained by summing all of the items. Total score ranges from 0 to 52. A higher score corresponds to a greater sexual dysfunction.
Measured: From baseline to 4 and 12 weeks of treatment
Amelioration of the vaginal maturation (VM) index
Amelioration of VMI in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. Vaginal maturation (VM) index is calculated quantifying the percentages of parabasal, intermediate, and superficial cells. The following formula is used: VMI = [1(% superficial cells)] + [0.6(% intermediate cells)] + [0.2(% parabasal cells)]. The index ranges from 0% to 100%.The higher the maturation index, the higher the number of mature 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: From baseline to 12 weeks of treatment
Patient's global assessment of overall satisfaction
Patient's global assessment of overall satisfaction in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group.Patient's global assessment (PTGA) is evaluated as the patient's overall satisfaction of the treatment scored on a four grade scale, ranging from 0 to 3 (0= dissatisfied or very dissatisfied, 1= moderately satisfied or satisfied, 2= very satisfied and 3= greatly satisfied). A higher score corresponds to a greater satisfaction.
Measured: 4 and 12 weeks of treatment
Ease in the method of Hyalo Gyn gel administration
Ease in the method of Hyalo Gyn gel administration will be reported by the patients as excellent, good, acceptable, bad or unacceptable
Measured: 4 and 12 weeks of treatment
Local tolerability at the application site
Local tolerability of Hyalo Gyn gel at the application site will be evaluated by both the clinician and the patient through a 5-point scale: 5 = excellent (no reaction), 4 = good (small reaction that spontaneously resolves), 3 = moderate (reaction tolerated with difficulty by the subject), 2 = poor (reaction needing interruption of treatment), 1 = bad (serious reaction)
Measured: 4 and 12 weeks of treatment
Safety of the treatment: Collection of adverse events
Collection of adverse events emerged as consequence of the product application and any other adverse event occurred during the study
Measured: 4 and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start5 Feb 2019
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal 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
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
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
- NCT04355403
- Sponsor's protocol ID
- QQ53-18-01
- Status last verified
- Apr 2020
- First submitted
- 17 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Open-label Clinical Investigation to Assess the Performance and Safety of Hyalo Gyn Gel Prefilled Applicators on the Treatment of Vaginal Atrophy in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04355403
- Acronym / sponsor ID
- QQ53-18-01
- Conditions
- Vulvovaginal Atrophy
- Keywords
- Hyaluronic Acid, Post-menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 21 Apr 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.
This clinical investigation evaluates the performance and safety of Hyalo Gyn, a hyaluronic acid derivative based vaginal gel for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyalo Gyn gel | Experimental | Device: Hyalo Gyn gel in prefilled applicatorsVaginal application of Hyalo Gyn gel in prefilled applicators |
| No treatment | No intervention | –No treatment application |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels >40 IU/L), both natural postmenopause or medical postmenopause (breast cancer patients undergoing a concurrent treatment with aromatase inhibitors or tamoxifen).
- Women between 18 and 75 years of age.
- Vaginal pH ≥5.
- Vulvovaginal atrophy with VHI < 15.
- At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity.
Key exclusion criteria (8 listed)
- Treatment with another investigational product within the previous 3 months.
- Previous participation in any clinical study with Hydeal-D based investigational products.
- Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
- Patients in previous treatment with either oral or topical hormonal products within 1 month.
- Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); history of vulvovaginal contact allergy or with a diagnose of vulvovaginal lichen.
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 gel in prefilled applicatorsOne vaginal application of Hyalo Gyn gel every 3 days to a total of 12 consecutive weeks. | Device | Hyalo Gyn gel |
Primary outcome
Change of patient's perception of vulvovaginal dryness
Time frame: From baseline to 12 weeks of treatment
Change of patient's perception of vulvovaginal dryness associated with vulvovaginal atrophy in postmenopausal women in Hyalo Gyn gel group compared to no-treatment group. The vulvovaginal dryness was reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe).
11 secondary outcomes
Change of patient's perception of vulvovaginal dryness
Time frame: From baseline to 4 weeks of treatment
Change of patient's perception of vulvovaginal symptoms
Time frame: From baseline to 4 and 12 weeks of treatment
Change of the average score of Vaginal Health Index (VHI)
Time frame: From baseline to 4 and 12 weeks of treatment
Change of vaginal pH
Time frame: From baseline to 4 and 12 weeks of treatment
Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)
Time frame: From baseline to 4 and 12 weeks of treatment
Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)
Time frame: From baseline to 4 and 12 weeks of treatment
Amelioration of the vaginal maturation (VM) index
Time frame: From baseline to 12 weeks of treatment
Patient's global assessment of overall satisfaction
Time frame: 4 and 12 weeks of treatment
Ease in the method of Hyalo Gyn gel administration
Time frame: 4 and 12 weeks of treatment
Local tolerability at the application site
Time frame: 4 and 12 weeks of treatment
Safety of the treatment: Collection of adverse events
Time frame: 4 and 12 weeks of treatment
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 21 Apr 2020.
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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.
2 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 gel in prefilled applicators in people with Vulvovaginal Atrophy, run by Fidia Farmaceutici s.p.a. at 2 sites in Slovakia.
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 7 inclusion and 8 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 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovakia. 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. 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?
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?
Change of patient's perception of vulvovaginal dryness (time frame: From baseline to 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 21 Apr 2020.