Vaginal DrynessPhase 4V-HYALNCT06964646
Assess Efficacy, Safety, and Tolerability of 8 Weeks of Vaginal Hyaluronic (V-HYAL) Gel in Peri- and Post-Menopausal Female
A Phase 4 study testing Vaginal Hyal gel 2.5g in people with Vaginal Dryness, run by University of Malaya at 1 site in Malaysia.
Trial summary
The goal of this clinical trial is to assess the efficacy of repeat doses of V-HYAL Gel on vaginal dryness in Peri- and Post-Menopausal Female. The main questions it aims to answer : To evaluate the effect of V-HYAL Gel on subjects' quality life. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Vaginal Dryness
- What is being tested?
- Vaginal Hyal gel 2.5g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMalaysia
- Study dates
- 8 Jan 2024to 27 Jun 2024
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peri or post-menopausal.
- BMI between 18 kg/m2 and 30 kg/m2.
- Able to give written informed consent before starting any study-related procedure.
- Medical history and physical examination normal or abnormal but not clinically relevant on the investigator judgment.
- ECG tracing, blood pressure and laboratory tests within normal range or abnormal but not clinically relevant as per the investigator's judgment.
- Not under any administrative or legal supervision.
- Sexually active in the last three months
Who cannot join
- Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
- Inability or unwillingness to provide written consent.
- Pregnancy, breastfeeding, or use of nonreliable methods of contraception.
- Other medical conditions which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
- History or evidence of allergy, idiosyncrasy or hypersensitivity to hyaluronic acid.
- History or clinical evidence of significant or uncontrolled cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal, haematological, neurological or psychiatric pathology which may affect the study outcomes.
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- Chronic diseases such as HIV I and II, HBV and HCV surgery within previous 6 months, or blood loss > 400 mL within previous 3 months.
- History of alcohol or drug abuse.
- Took hormone therapy or tibolone in the 3 months before the first dosing occasion and during the study.
- Took any pharmacological treatment which may affect the vaginal dryness or study outcomes, such as Menopausal Hormone Therapy (except for symptomatic short-term paracetamol use)
- Received concomitant treatment with other investigational drugs or had participated in another clinical trial within the previous 6 months prior to dosing / 4 weeks prior to screening visit.
- Had any surgery or medical treatment which may interfere with study outcomes (i.e. hysterectomy).
- Any subject who cannot be contacted in case of emergency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy, Safety, and Tolerability of 8 Weeks of Vaginal Hyaluronic (V-HYAL) Gel in Peri- and Post-Menopausal Female
The goal of this clinical trial is to assess the efficacy of repeat doses of V-HYAL Gel on vaginal dryness in Peri- and Post-Menopausal Female. The main questions it aims to answer :
- To evaluate the effect of V-HYAL Gel on subjects' quality life.
- To evaluate the effect of V-HYAL Gel on the vaginal lactobacillus flora, vaginal thrush, bacterial vaginosis and trichomonas vaginalis
- To evaluate the safety and tolerability of repeat doses of V-HYAL Gel. Researchers will compare V-Hyal treated arm to see for its efficacy and safety.
Participants will have screening visit for the evaluation of subject's eligibility and three study days, Day 0 (Baseline), Week 4 (Telephone contact), and Week 8 (End of study visit). Primary criterion: Visual Analogic Scale (VAS) of vaginal dryness Secondary criterion: Vaginal microbiota and immunology HRQoL(SF 8), DIVA, FSFI questionnaires Patient Global Impression of Improvement Vaginal PH VHI scale.
Read the detailed description
Primary outcome:
The primary outcome was the subjective performance evaluation in terms of the Visual Analogic Scale (VAS) for vaginal dryness was used as the primary criteria for determining the results of the trial. VAS was assessed at baseline (Day 0), during a telephone contact after the fifth administration, and at the final visit (week 8) after 19 administrations. VAS assessed are vaginal dryness, vaginal itching, vaginal irritation, and painful urination (0-10, 0 = absent, 10 = intolerable). Between-group differences in the proportion of patients with a reduction in VAS score at week 8, at p-value < 0.05 significant.
Secondary outcome:
Criteria to be used as secondary outcomes are as follows:
- High vaginal swab (HVS) to measure vagina lactobacillus flora, vaginal thrush, bacterial vaginosis and trichomonas vaginalis was done by taking a High Vaginal Swab (HVS) from the posterior fornix and observing the intensity and variety of microflora.
- pH measurements were taken using pH strips.
- Adverse events include any form of vaginal bleeding, bothersome vaginal irritations, bacterial vaginosis, vaginal yeast infection and hypersensitivity reactions.
- Vaginal Health Index (VHI) (cut-off < 15 index of atrophic vagina) and between-group difference in mean change from baseline to end of study (week 8) Female Sexual Function Index Scoring (FSFI)
- Day-to-day Impact of Vaginal Aging Questionnaire (DIVA)
- Conditions
- Vaginal Dryness
- Being tested
- Vaginal Hyal gel 2.5g
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Hyal gel 2.5gDrug
vaginal gel 2.5g
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (with V-HYAL Gel (formerly Vaginal Hyal Gel)) | Experimental | Given 2.5g of Vaginal Hyal gel Receives: Drug: Vaginal Hyal gel 2.5g |
| Control group | No intervention | No intervention control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogic Scale (VAS)
Subjective performance evaluation in terms of the Visual Analogic Scale (VAS) for vaginal dryness was used as the primary criteria for determining the results of the trial.VAS assessed are vaginal dryness, vaginal itching, vaginal irritation, and painful urination (0-10, 0 = absent, 10 = intolerable). Between-group differences in the proportion of patients with a reduction in VAS score at week 8, at p-value < 0.05 significant.
Measured: . VAS was assessed at baseline (Day 0), during a telephone contact after the fifth administration (Week 4), and at the final visit (week 8) after 19 administrations.
Secondary outcomes (5)
High Vaginal Swab
Measure vagina lactobacillus flora, vaginal thrush, bacterial vaginosis and trichomonas vaginalis was done by taking a High Vaginal Swab (HVS) from the posterior fornix and observing the intensity and variety of microflora
Measured: 8 weeks
Vaginal pH
pH measurements were taken using pH strips before and after using the investigational product
Measured: 8 weeks
Vaginal Health Index
Vaginal Health Index (VHI) (cut-off < 15 index of atrophic vagina) and between-group difference in mean change from baseline to end of study (week 8)
Measured: 8 weeks
Female Sexual Function Index Scoring (FSFI)
Female Sexual Function Index Scoring (FSFI) between-group difference in mean change from baseline to end of study (week 8) The Female Sexual Function Index (FSFI) is a standardized, 19-item questionnaire used to assess sexual function in women across six key domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain includes a specific number of questions with responses scored on a Likert scale, typically ranging from 0 or 1 to 5. Domain scores are calculated by summing the scores of the relevant questions and multiplying by a domain-specific factor: desire (×0.6), arousal (×0.3), lubrication (×0.3), orgasm (×0.4), satisfaction (×0.4), and pain (×0.4). The total FSFI score is the sum of these six domain scores, with a maximum possible score of 36. A total score of 26.55 or lower is generally considered indicative of female sexual dysfunction.
Measured: 8 weeks
Day-to-day Impact of Vaginal Aging (DIVA)
The DIVA questionnaire includes 23 items distributed across four domains: daily activities (5 items), emotional well-being (4 items), sexual functioning (9 items), and self-concept/body image (5 items). Each item is rated on a 5-point Likert scale from 1 (no impact) to 5 (very severe impact), with higher scores indicating greater negative impact. For each domain, the scores of individual items are averaged to produce a mean domain score, rather than summed, ensuring comparability across domains with different numbers of items.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start8 Jan 2024
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
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 Vaginal DrynessStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Model description
- The intervention group received repeat doses of 2.5g of V-HYAL Gel® (formerly Vaginal Hyal Gel) every three days, while the control group did not receive the gel.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hasniza Zaman Huri Prof, Doctor of Philosophy, Study chair, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964646
- Sponsor's protocol ID
- VDMEN-V4.0-2023
- Other IDs
- NMRR ID-23-02085-IH7
- Acronym
- V-HYAL
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen J, Geng L, Song X, Li H, Giordan N, Liao Q. Evaluation of the efficacy and safety of hyaluronic acid vaginal gel to ease vaginal dryness: a multicenter, randomized, controlled, open-label, parallel-group, clinical trial. J Sex Med. 2013 Jun;10(6):1575-84. doi: 10.1111/jsm.12125. Epub 2013 Apr 9.
PubMed 23574713
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, and Tolerability of 8 Weeks of Vaginal Hyaluronic (V-HYAL) Gel in Peri- and Post-Menopausal Female
- ClinicalTrials.gov ID
- NCT06964646
- Acronym / sponsor ID
- V-HYAL / VDMEN-V4.0-2023
- Conditions
- Vaginal Dryness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 9 May 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.
The goal of this clinical trial is to assess the efficacy of repeat doses of V-HYAL Gel on vaginal dryness in Peri- and Post-Menopausal Female. The main questions it aims to answer :
- To evaluate the effect of V-HYAL Gel on subjects' quality life.
- To evaluate the effect of V-HYAL Gel on the vaginal lactobacillus flora, vaginal thrush, bacterial vaginosis and trichomonas vaginalis
- To evaluate the safety and tolerability of repeat doses of V-HYAL Gel. Researchers will compare V-Hyal treated arm to see for its efficacy and safety.
Participants will have screening visit for the evaluation of subject's eligibility and three study days, Day 0 (Baseline), Week 4 (Telephone contact), and Week 8 (End of study visit). Primary criterion: Visual Analogic Scale (VAS) of vaginal dryness Secondary criterion: Vaginal microbiota and immunology HRQoL(SF 8), DIVA, FSFI questionnaires Patient Global Impression of Improvement Vaginal PH VHI scale.
Detailed description
Primary outcome:
The primary outcome was the subjective performance evaluation in terms of the Visual Analogic Scale (VAS) for vaginal dryness was used as the primary criteria for determining the results of the trial. VAS was assessed at baseline (Day 0), during a telephone contact after the fifth administration, and at the final visit (week 8) after 19 administrations. VAS assessed are vaginal dryness, vaginal itching, vaginal irritation, and painful urination (0-10, 0 = absent, 10 = intolerable). Between-group differences in the proportion of patients with a reduction in VAS score at week 8, at p-value < 0.05 significant.
Secondary outcome:
Criteria to be used as secondary outcomes are as follows:
- High vaginal swab (HVS) to measure vagina lactobacillus flora, vaginal thrush, bacterial vaginosis and trichomonas vaginalis was done by taking a High Vaginal Swab (HVS) from the posterior fornix and observing the intensity and variety of microflora.
- pH measurements were taken using pH strips.
- Adverse events include any form of vaginal bleeding, bothersome vaginal irritations, bacterial vaginosis, vaginal yeast infection and hypersensitivity reactions.
- Vaginal Health Index (VHI) (cut-off < 15 index of atrophic vagina) and between-group difference in mean change from baseline to end of study (week 8) Female Sexual Function Index Scoring (FSFI)
- Day-to-day Impact of Vaginal Aging Questionnaire (DIVA)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention group received repeat doses of 2.5g of V-HYAL Gel® (formerly Vaginal Hyal Gel) every three days, while the control group did not receive the gel.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (with V-HYAL Gel (formerly Vaginal Hyal Gel)) | Experimental | Drug: Vaginal Hyal gel 2.5gGiven 2.5g of Vaginal Hyal gel |
| Control group | No intervention | –No intervention control group |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Peri or post-menopausal.
- BMI between 18 kg/m2 and 30 kg/m2.
- Able to give written informed consent before starting any study-related procedure.
- Medical history and physical examination normal or abnormal but not clinically relevant on the investigator judgment.
- ECG tracing, blood pressure and laboratory tests within normal range or abnormal but not clinically relevant as per the investigator's judgment.
Key exclusion criteria (13 listed)
- Inability or unwillingness to comply with the requirements of the protocol as determined by the investigator.
- Inability or unwillingness to provide written consent.
- Pregnancy, breastfeeding, or use of nonreliable methods of contraception.
- Other medical conditions which, in the investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
- History or evidence of allergy, idiosyncrasy or hypersensitivity to hyaluronic acid.
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 Hyal gel 2.5gvaginal gel 2.5g | Drug | Intervention Group (with V-HYAL Gel (formerly Vaginal Hyal Gel)) |
Primary outcome
Visual Analogic Scale (VAS)
Time frame: . VAS was assessed at baseline (Day 0), during a telephone contact after the fifth administration (Week 4), and at the final visit (week 8) after 19 administrations.
Subjective performance evaluation in terms of the Visual Analogic Scale (VAS) for vaginal dryness was used as the primary criteria for determining the results of the trial.VAS assessed are vaginal dryness, vaginal itching, vaginal irritation, and painful urination (0-10, 0 = absent, 10 = intolerable). Between-group differences in the proportion of patients with a reduction in VAS score at week 8, at p-value < 0.05 significant.
5 secondary outcomes
High Vaginal Swab
Time frame: 8 weeks
Vaginal pH
Time frame: 8 weeks
Vaginal Health Index
Time frame: 8 weeks
Female Sexual Function Index Scoring (FSFI)
Time frame: 8 weeks
Day-to-day Impact of Vaginal Aging (DIVA)
Time frame: 8 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 9 May 2025.
- Background: PubMed 23574713Chen J, Geng L, Song X, Li H, Giordan N, Liao Q. Evaluation of the efficacy and safety of hyaluronic acid vaginal gel to ease vaginal dryness: a multicenter, randomized, controlled, open-label, parallel-group, clinical trial. J Sex Med. 2013 Jun;10(6):1575-84. doi: 10.1111/jsm.12125. Epub 2013 Apr 9.
- 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.
Hasniza Zaman Huri Prof, Doctor of Philosophy study chair
University of Malaya
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 Hyal gel 2.5g in people with Vaginal Dryness, run by University of Malaya at 1 site in Malaysia.
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 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: finished, as of the sponsor's last update on 9 May 2025. 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 Malaysia. 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.
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?
Visual Analogic Scale (VAS) (time frame: . VAS was assessed at baseline (Day 0), during a telephone contact after the fifth administration (Week 4), and at the final visit (week 8) after 19 administrations.). 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 NCT06964646, 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 9 May 2025.