VaginismusPhase 3NCT06564883
Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women
A Phase 3 study testing 0.20% sodium hyaluronate gel in people with Vaginismus and Vaginal Atrophy, run by Biolab Sanus Farmaceutica.
Trial summary
Hyaluronic Acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vaginismus, Vaginal Atrophy, Menopause
- What is being tested?
- 0.20% sodium hyaluronate gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 30 Oct 2025
- Phase
- Phase 3
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy research participants, with an active sexual life;
- Intact skin and mucosa in the test region;
- Participants vaccinated for COVID-19 (Corona virus Disease).
- Agreement to adhere to the study procedures and requirements and attend the institute on the day(s) and time(s) determined for the assessments;
- Ability to consent to participate in the study;
- Menopausal participants of any age, without systemic or topical hormone replacement therapy in the last 6 months
- Presenting mild to moderate vaginal dryness (≥0.5 and <7.5) - according to the Visual Analogic Scale
- Healthy research participants, with an active sex life (at least once a week)
Who cannot join
- Skin pathology in the area of product application;
- Decompensated Diabetes Mellitus (TBD by the institute together with the sponsor);
- Immune insufficiency;
- Current use of the following topical or systemic medications: corticosteroids, immunosuppressants and antihistamines;
- Skin diseases: vitiligo, psoriasis, atopic dermatitis;
- Previous reaction to the category of the product tested;
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- Other illnesses or medications that may directly interfere with the study or put the health of the research participant at risk.
- Have used vaginal moisturizing creams and/or intimate lubricants 5 days before the initial study visit;
- Have had sexual intercourse at least 48 hours before the initial study visit;
- Have been diagnosed with a urogenital or vaginal infection in the last 30 days;
- Have used topical or systemic antibiotics, antifungals, hormone-based creams or treatment for vaginal atrophy in the last 30 days.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of Hydration and Acceptability of the Genital and Cutaneous Mucosa of a Vaginal Moisturizer in Vaginal Dryness in Menopausal Women
Hyaluronic Acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours. Hyaluronic Acid promotes vaginal moisture, providing symptom relief in various situations such as:
- Vaginismus and other sexual dysfunctions related to penetration
- Users of hormonal contraceptives with lubrication loss
- Postpartum and lactational period
- Post antibacterial or antifungal therapies
- During systemic oncological treatments (chemotherapy, radiotherapy, hormone therapy)
- Climacteric (urogenital atrophy)
- Post urogynecological surgeries (correction of urinary incontinence, genital dystopias, etc.)
- Post vulvovaginal abrasive, chemical, laser, or high-frequency therapies
- Post cosmetic and genital rejuvenation therapies
- Conditions
- Vaginismus, Vaginal Atrophy, Menopause
- Being tested
- 0.20% sodium hyaluronate gel
- Medical subject headings
- Vaginismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.20% sodium hyaluronate gelDevice
Also called Hyaluronic Acid
Hyaluronic Acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Hyaluronic Acid will applied under recommended conditions during the period of T22 ±2 days. Receives: Device: 0.20% sodium hyaluronate gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verify the hydration of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
To evaluate the perceived hydration effectiveness, a visual analogue scale will be used, where the minimum value (zero) represents no dryness and the maximum value (ten) represents extremely dryness. Lower scores indicate improved vaginal hydration.
Measured: 22 days
Verify the acceptability of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
To assess skin acceptability, an epithelial integrity questionnaire will be used, where a score, on a 5-point scale, will be assigned after evaluation by the gynecologist. The lowest score will be 1, representing "petechiae before contact" and the maximum score will be 5 with "thin, non-friable mucosa". The higher the score, the healthier and more intact the epithelium will be.
Measured: 22 days
Secondary outcomes (3)
Relief of pruritus after using hyaluronic acid-based vaginal gel
The relief of pruritus assessment will be evaluates through an Visual Analogic Scale. Where the minimum value (zero) represents no pruritus and the maximum value (ten) represents extremely pruritus. Lower scores indicate improvement or absence of vaginal pruritus.
Measured: 22 days
Verify the maintenance of pH after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.
pH maintenance will be assessed using reagent strips.
Measured: 22 days
Verify the maintenance of vaginal microbiota after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.
Bacterioscopic collection of vaginal contents using a sterile swab. The swabs containing the samples will be placed in test tubes sent to the laboratory for microbiological analysis.
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginismusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564883
- Sponsor's protocol ID
- BS-GIMM24
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hydration and Acceptability of the Genital and Cutaneous Mucosa of a Vaginal Moisturizer in Vaginal Dryness in Menopausal Women
- ClinicalTrials.gov ID
- NCT06564883
- Acronym / sponsor ID
- BS-GIMM24
- Conditions
- Vaginismus, Vaginal Atrophy, Menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 21 Aug 2024 (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.
Hyaluronic Acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours. Hyaluronic Acid promotes vaginal moisture, providing symptom relief in various situations such as:
- Vaginismus and other sexual dysfunctions related to penetration
- Users of hormonal contraceptives with lubrication loss
- Postpartum and lactational period
- Post antibacterial or antifungal therapies
- During systemic oncological treatments (chemotherapy, radiotherapy, hormone therapy)
- Climacteric (urogenital atrophy)
- Post urogynecological surgeries (correction of urinary incontinence, genital dystopias, etc.)
- Post vulvovaginal abrasive, chemical, laser, or high-frequency therapies
- Post cosmetic and genital rejuvenation therapies
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: 0.20% sodium hyaluronate gelHyaluronic Acid will applied under recommended conditions during the period of T22 ±2 days. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy research participants, with an active sexual life;
- Intact skin and mucosa in the test region;
- Participants vaccinated for COVID-19 (Corona virus Disease).
- Agreement to adhere to the study procedures and requirements and attend the institute on the day(s) and time(s) determined for the assessments;
- Ability to consent to participate in the study;
Key exclusion criteria (11 listed)
- Skin pathology in the area of product application;
- Decompensated Diabetes Mellitus (TBD by the institute together with the sponsor);
- Immune insufficiency;
- Current use of the following topical or systemic medications: corticosteroids, immunosuppressants and antihistamines;
- Skin diseases: vitiligo, psoriasis, atopic dermatitis;
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 |
|---|---|---|
| 0.20% sodium hyaluronate gelAlso: Hyaluronic AcidHyaluronic Acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours. | Device | Experimental Arm |
Primary outcome
Verify the hydration of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
Time frame: 22 days
To evaluate the perceived hydration effectiveness, a visual analogue scale will be used, where the minimum value (zero) represents no dryness and the maximum value (ten) represents extremely dryness. Lower scores indicate improved vaginal hydration.
Verify the acceptability of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel
Time frame: 22 days
To assess skin acceptability, an epithelial integrity questionnaire will be used, where a score, on a 5-point scale, will be assigned after evaluation by the gynecologist. The lowest score will be 1, representing "petechiae before contact" and the maximum score will be 5 with "thin, non-friable mucosa". The higher the score, the healthier and more intact the epithelium will be.
3 secondary outcomes
Relief of pruritus after using hyaluronic acid-based vaginal gel
Time frame: 22 days
Verify the maintenance of pH after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.
Time frame: 22 days
Verify the maintenance of vaginal microbiota after using Hyaluronic Acid when applied under recommended conditions of use through gynecologist follow-up during the use.
Time frame: 22 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.20% sodium hyaluronate gel in people with Vaginismus and Vaginal Atrophy, run by Biolab Sanus Farmaceutica.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Guerra Filho, MD (+55 19 37898610, negocios@grupoinvestiga.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verify the hydration of the cutaneous and genital mucosa after using hyaluronic acid-based vaginal gel (time frame: 22 days). The study lists 2 primary outcomes in all. 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 Aug 2024.