Menopause SyndromeNCT05263102
Evaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause
A study testing Vaginal Moisturizing Gel in people with Menopause Syndrome, run by HAN Biomedical Inc at 4 sites in Taiwan.
Trial summary
The aim of the study is to evaluate the safety and efficacy of the vaginal gel with HMW HA in women with genitourinary syndromes due to either menopause or other causes such as the patients after ovarian or breast cancer diagnosis and treatment. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Menopause Syndrome
- What is being tested?
- Vaginal Moisturizing Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesTaiwan
- Study dates
- 1 Mar 2020to 13 Aug 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects have been diagnosed with cervical or vaginal malignant neoplasms
- Subjects with abnormal undiagnostic genital bleeding
- Subject with active vaginal infection
- Subjects with vaginal pH value < 4.5
- Subjects are under hormone replacement therapy within three months
- Subjects are under phytoestrogen treatment within two month
- Subjects use of vaginal douche, lubricant or moisturizer in one week
- Subjects are hypersensitive to sodium hyaluronate, carrageenan
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Changhua Christian Hospital
Changhua
China Medical University Hospital
Taichung
Chi Mei Medical Center
Tainan
National Taiwan University Hospital
Taipei
About this study
The aim of the study is to evaluate the safety and efficacy of the vaginal gel with HMW HA in women with genitourinary syndromes due to either menopause or other causes such as the patients after ovarian or breast cancer diagnosis and treatment.
Read the detailed description
It was recognized that GSM is likely to be underdiagnosed and undertreated9. The North American Menopause Society (NAMS) issued the treatment guideline of GSM in 2014 and encouraged the physicians and nurses to pursue menopausal women to check if they have genitourinary syndrome. GSM is considered a progressive condition in menopausal women, and the primary goal of treatment strategy is symptom relief. Options include lifestyle changes, non-hormonal, and hormonal treatments. Hormonal therapies include both topical and systemic approaches. However, many women reported that substantial concerns about the long-term safety of hormonal products.The patients are aware of the possible relationship between cancer, heart disease, stroke, and estrogen-based treatments10. For considering long-term treatment strategy, estrogen free products of vaginal lubricant or vaginal moisturizer are recommended as first line treatment for those with mild to moderate syndrome.
- Conditions
- Menopause Syndrome
- Being tested
- Vaginal Moisturizing Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Moisturizing GelDevice
All eligible subjects will received the Vaginal Moisturizing Gel twice per week, total in 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Treatment duration: 8 weeks Twice treatments per week Receives: Device: Vaginal Moisturizing Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
pH value change
The change of the vaginal pH value
Measured: from baseline to week 8
Secondary outcomes (2)
The Questionnaire of Genitourinary Syndromes of Menopause
The change of its severity is used to evaluate symptomatic improvement. The minimum value is 0 and maximum value is 3, where higher scores mean a worse outcome.
Measured: from baseline to week 8
Vaginal maturation index (VMI)
The change of its value is used to evaluate the maturation of the vaginal epithelial cells
Measured: from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Mar 2020
- Primary completion13 Aug 2022
- Study completion13 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- before and after treatment
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAN Biomedical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263102
- Sponsor's protocol ID
- HAN2014005-CT02
- Status last verified
- Dec 2022
- First submitted
- 21 Feb 2022
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of A High Molecular Weight, Natural Hyaluronic Acid Vaginal Gel in Women With Genitourinary Syndrome of Menopause
- ClinicalTrials.gov ID
- NCT05263102
- Acronym / sponsor ID
- HAN2014005-CT02
- Conditions
- Menopause Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- HAN Biomedical IncIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 13 Aug 2022 (actual)
- Study completion
- 13 Aug 2022 (actual)
- First posted
- 2 Mar 2022 (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 aim of the study is to evaluate the safety and efficacy of the vaginal gel with HMW HA in women with genitourinary syndromes due to either menopause or other causes such as the patients after ovarian or breast cancer diagnosis and treatment.
Detailed description
It was recognized that GSM is likely to be underdiagnosed and undertreated9. The North American Menopause Society (NAMS) issued the treatment guideline of GSM in 2014 and encouraged the physicians and nurses to pursue menopausal women to check if they have genitourinary syndrome. GSM is considered a progressive condition in menopausal women, and the primary goal of treatment strategy is symptom relief. Options include lifestyle changes, non-hormonal, and hormonal treatments. Hormonal therapies include both topical and systemic approaches. However, many women reported that substantial concerns about the long-term safety of hormonal products.The patients are aware of the possible relationship between cancer, heart disease, stroke, and estrogen-based treatments10. For considering long-term treatment strategy, estrogen free products of vaginal lubricant or vaginal moisturizer are recommended as first line treatment for those with mild to moderate syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before and after treatment
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Vaginal Moisturizing GelTreatment duration: 8 weeks Twice treatments per week |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Subjects have been diagnosed with cervical or vaginal malignant neoplasms
- Subjects with abnormal undiagnostic genital bleeding
- Subject with active vaginal infection
- Subjects with vaginal pH value < 4.5
- Subjects are under hormone replacement therapy within three months
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 Moisturizing GelAll eligible subjects will received the Vaginal Moisturizing Gel twice per week, total in 8 weeks | Device | Treatment Arm |
Primary outcome
pH value change
Time frame: from baseline to week 8
The change of the vaginal pH value
2 secondary outcomes
The Questionnaire of Genitourinary Syndromes of Menopause
Time frame: from baseline to week 8
Vaginal maturation index (VMI)
Time frame: from baseline to week 8
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 3 Jan 2023.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Moisturizing Gel in people with Menopause Syndrome, run by HAN Biomedical Inc at 4 sites in Taiwan.
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 0 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 3 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 4 sites in Taiwan. 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?
pH value change (time frame: from baseline to week 8). 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 3 Jan 2023.