Genitourinary Syndrome of Menopause (GSM)NCT07038070
Via, a Hyaluronic Acid (HLA) Based Vaginal Moisturizer Study
A study testing Vaginal estrogen tablet and Via Solv Wellness (Hyaluronic Acid Therapy) in people with Genitourinary Syndrome of Menopause (GSM), run by NYU Langone Health at 1 site in United States.
Trial summary
This study aims to evaluate whether the administration of vaginal estrogen along with Via, a hyaluronic acid-based vaginal moisturizer, offers superior relief from symptoms of genitourinary syndrome of menopause (GSM) in the urogynecologic patient population, compared to administration of vaginal estrogen alone. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause (GSM)
- What is being tested?
- Vaginal estrogen tablet and Via Solv Wellness (Hyaluronic Acid Therapy)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 1 May 2026
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal (last menstrual period at least 12 months ago).
- Aged 45 years or older and have symptoms of Genitourinary Syndrome of Menopause (GSM).
- Have never tried vaginal estrogen therapy, or have tried vaginal estrogen therapy, but have not used vaginal estrogen and/or hyaluronic acid products for management of GSM symptoms within the last 3 months.
- Capable of signing informed consent.
- Capable and willing to follow all study-relation visits.
Who cannot join
- Subjects currently diagnosed with or undergoing treatment for hormone-sensitive disease (e.g. breast cancer)
- Subjects currently using systemic hormone replacement therapy
- Subjects currently using estrogen hormonal therapies or hormone modulators (aromatase inhibitors or selective estrogen receptor modulators)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing the Efficacy of Topical Vaginal Estrogen Versus Topical Vaginal Estrogen Plus Via, a Hyaluronic Acid-Based Vaginal Moisturizer, in the Treatment of Genitourinary Syndrome of Menopause
This study aims to evaluate whether the administration of vaginal estrogen along with Via, a hyaluronic acid-based vaginal moisturizer, offers superior relief from symptoms of genitourinary syndrome of menopause (GSM) in the urogynecologic patient population, compared to administration of vaginal estrogen alone.
- Being tested
- Vaginal estrogen tablet, Via Solv Wellness (Hyaluronic Acid Therapy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal estrogen tabletDrug
The dosage of the vaginal estrogen will be one 10mcg tablet administered vaginally nightly for 2 weeks, then administered vaginally twice weekly for 14 weeks.
Via Solv Wellness (Hyaluronic Acid Therapy)Device
The dosage of Via will be a pea-sized amount applied vaginally along the vaginal and vulvar walls nightly for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Estrogen + Hyaluronic acid (HLA) | Experimental | Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. Participants will concomitantly apply Via (Hyaluronic acid) nightly for 16 weeks. Receives: Drug: Vaginal estrogen tablet; Device: Via Solv Wellness (Hyaluronic Acid Therapy) |
| Vaginal Estrogen Alone | Active comparator | Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. Receives: Drug: Vaginal estrogen tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in vulvovaginal symptom questionnaire (VSQ) score
The VSQ is a 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.
Measured: Baseline, Week 16
Secondary outcomes (3)
Percent change in vaginal pH
Measured: Baseline, Week 16
Change in vaginal maturation index (VMI)
The number of parabasal cells, intermediate cells, and superficial cells will be counted, and the maturation index will be calculated as the percent basal cells visualized.
Measured: Baseline, Week 16
Number of adverse events related to treatment
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Why it stopped: The study was placed on hold by the Sponsor for \~1 year. Given the prolonged hold and absence of participant activity, the study was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of Menopause (GSM)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Brucker, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038070
- Sponsor's protocol ID
- 25-00415
- Status last verified
- Apr 2026
- First submitted
- 18 Jun 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to benajmin.brucker@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Efficacy of Topical Vaginal Estrogen Versus Topical Vaginal Estrogen Plus Via, a Hyaluronic Acid-Based Vaginal Moisturizer, in the Treatment of Genitourinary Syndrome of Menopause
- ClinicalTrials.gov ID
- NCT07038070
- Acronym / sponsor ID
- 25-00415
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was placed on hold by the Sponsor for \~1 year. Given the prolonged hold and absence of participant activity, the study was closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 26 Jun 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.
This study aims to evaluate whether the administration of vaginal estrogen along with Via, a hyaluronic acid-based vaginal moisturizer, offers superior relief from symptoms of genitourinary syndrome of menopause (GSM) in the urogynecologic patient population, compared to administration of vaginal estrogen alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Estrogen + Hyaluronic acid (HLA) | Experimental | Drug: Vaginal estrogen tablet, Device: Via Solv Wellness (Hyaluronic Acid Therapy)Participants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. Participants will concomitantly apply Via (Hyaluronic acid) nightly for 16 weeks. |
| Vaginal Estrogen Alone | Active comparator | Drug: Vaginal estrogen tabletParticipants will administer vaginal estrogen tablets nightly for 2 weeks, then twice weekly for 14 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Postmenopausal (last menstrual period at least 12 months ago).
- Aged 45 years or older and have symptoms of Genitourinary Syndrome of Menopause (GSM).
- Have never tried vaginal estrogen therapy, or have tried vaginal estrogen therapy, but have not used vaginal estrogen and/or hyaluronic acid products for management of GSM symptoms within the last 3 months.
- Capable of signing informed consent.
- Capable and willing to follow all study-relation visits.
Key exclusion criteria (3 listed)
- Subjects currently diagnosed with or undergoing treatment for hormone-sensitive disease (e.g. breast cancer)
- Subjects currently using systemic hormone replacement therapy
- Subjects currently using estrogen hormonal therapies or hormone modulators (aromatase inhibitors or selective estrogen receptor modulators)
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 estrogen tabletThe dosage of the vaginal estrogen will be one 10mcg tablet administered vaginally nightly for 2 weeks, then administered vaginally twice weekly for 14 weeks. | Drug | Vaginal Estrogen + Hyaluronic acid (HLA), Vaginal Estrogen Alone |
| Via Solv Wellness (Hyaluronic Acid Therapy)The dosage of Via will be a pea-sized amount applied vaginally along the vaginal and vulvar walls nightly for 16 weeks. | Device | Vaginal Estrogen + Hyaluronic acid (HLA) |
Primary outcome
Percent change in vulvovaginal symptom questionnaire (VSQ) score
Time frame: Baseline, Week 16
The VSQ is a 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.
3 secondary outcomes
Percent change in vaginal pH
Time frame: Baseline, Week 16
Change in vaginal maturation index (VMI)
Time frame: Baseline, Week 16
Number of adverse events related to treatment
Time frame: Week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Yes. The individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to benajmin.brucker@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Related trials for Genitourinary Syndrome of Menopause (GSM)
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
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Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
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Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
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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.
Benjamin Brucker principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal estrogen tablet and Via Solv Wellness (Hyaluronic Acid Therapy) in people with Genitourinary Syndrome of Menopause (GSM), run by NYU Langone Health at 1 site in United States.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 4 May 2026. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percent change in vulvovaginal symptom questionnaire (VSQ) score (time frame: Baseline, Week 16). 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 4 May 2026.