Genitourinary Syndrome of MenopauseVITAL-ENCT05672901
Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause
A study testing StrataMGT and Estrace 0.01% Vaginal Cream in people with Genitourinary Syndrome of Menopause, run by Stratpharma AG at 3 sites in United States.
Trial summary
The goal of this randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is: Will StrataMGT be non-inferior regarding patient quality of life compared to standard of care?… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- StrataMGT and Estrace 0.01% Vaginal Cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Apr 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- Confirmed postmenopausal age
- Diagnosed genitourinary syndrome of menopause
- Access to a smartphone, tablet or computer, and to a functional email address.
Who cannot join
- Contraindication for the use of estrogen therapy
- Unable to provide informed consent
- Patient unable to apply topical device
- Allergy or intolerance to ingredients or excipients of the formulation of studied products
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
One Health Research Clinic
Johns Creek, Georgia, 30097
David Montaldi, DO, 678-585-4917, sylvia@ohrclinic.com
- Recruiting
Orange Coast Women's Medical Group
Laguna Hills, California, 92653
Ellen Winter, +1 949 829 5500, ellenmwinter@gmail.com
Marc Winter, M.D.
- Recruiting
Abba Medical Group
Miami, Florida, 33176
Dr. Jorge Fernandez, 786-353-2536, mc@abbamedicalresearch.com
About this study
Official title: Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial
The goal of this randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is:
- Will StrataMGT be non-inferior regarding patient quality of life compared to standard of care?
Participants will use either StrataMGT or estrogen vaginal cream to treat GSM for 3 consecutive months. After the baseline assessment, participants will be assessed monthly for quality of life, clinical signs, symptoms, pathology and adverse reactions.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- StrataMGT, Estrace 0.01% Vaginal Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrataMGTDevice
StrataMGT is a 100% medical grade film-forming silicone gel for the treatment of cutaneous skin lesions and Genitourinary Syndrome of Menopause. StrataMGT is a flexible wound dressing used on compromised skin. It dries to form a thin, flexible wound dressing which hydrates and protects affected areas. StrataMGT is used to relieve low grade inflammatory changes such as dry, itching, flaking, peeling and irritated skin. StrataMGT is designed for partially epithelized skin and is suitable for children and patients with sensitive skin.
Estrace 0.01% Vaginal CreamDrug
Estrace is a prescriptive female hormone indicated in the treatment of moderate to severe symptoms of Genitourinary Syndrome of Menopause.
| Study group | Role | What they receive |
|---|---|---|
| StrataMGT | Experimental | Participants will apply StrataMGT (silicone gel) 2-5 times daily (no limit in application times) to treat GSM for 3 months. Receives: Device: StrataMGT |
| Estrace | Active comparator | Participants will receive Estrace vaginal cream (estrogen) to treat GSM for 3 months. Application will be 1 g daily for the first two weeks. Afterwards, a maintenance dosage of 1 g three times a week is applied. Receives: Drug: Estrace 0.01% Vaginal Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROM: Quality of Life
The improvement of patient quality of life will be assessed at baseline and during each monthly follow-up using the patient-rated Vulvar Disease Quality of Life (VQLI) Index questionnaire. Questions are rated on a numeric scale from 0 (not at all) - 3 (very much). This outcome is patient-rated, thus unblinded.
Measured: 3 months
Secondary outcomes (7)
Clinical signs
Signs are rated by the investigator (blinded) during baseline and at the final visit after 3 months, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible.
Measured: 3 months
Adverse Reactions
Adverse reactions are rated by the investigator (blinded) during baseline and at the final visit after 3 months, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible.
Measured: 3 months
Visual pathology
Severity of the visual pathology is rated by the investigator (blinded) during baseline and at the final visit after 3 months, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible.
Measured: 3 months
PROM: Symptoms
Symptoms are rated by the patient at baseline and during each monthly follow-up, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. This outcome is patient-rated, thus unblinded.
Measured: 3 months
PROM: Dyspareunia
Dyspareunia is rated by the patient at baseline and during each monthly follow-up, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. This outcome is patient-rated, thus unblinded.
Measured: 3 months
PROM: Product Rating
Product performance is rated by the patient at the final visit after 3 months, using a Likert scale from 1=unsatisfactory to 5=excellent. This outcome is patient-rated, thus unblinded.
Measured: 3 months
PROM: Treatment Adherence
Treatment adherence is reported by the patient during the final study assessment, indicating the number of days/week and times/day the product was applied during the previous month. Percentage of treatment adherence is calculated from the minimum required treatment schedule.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start4 Apr 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of MenopauseStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stratpharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672901
- Sponsor's protocol ID
- SPAMG02
- Acronym
- VITAL-E
- Status last verified
- Feb 2026
- First submitted
- 3 Jan 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05672901
- Acronym / sponsor ID
- VITAL-E / SPAMG02
- Conditions
- Genitourinary Syndrome of Menopause
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stratpharma AGIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Jan 2023 (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 randomized controlled trial is to test the efficacy of StrataMGT in the management of Genitourinary Syndrome of Menopause (GSM) compared to estrogen therapy. The main question it aims to answer is:
- Will StrataMGT be non-inferior regarding patient quality of life compared to standard of care?
Participants will use either StrataMGT or estrogen vaginal cream to treat GSM for 3 consecutive months. After the baseline assessment, participants will be assessed monthly for quality of life, clinical signs, symptoms, pathology and adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StrataMGT | Experimental | Device: StrataMGTParticipants will apply StrataMGT (silicone gel) 2-5 times daily (no limit in application times) to treat GSM for 3 months. |
| Estrace | Active comparator | Drug: Estrace 0.01% Vaginal CreamParticipants will receive Estrace vaginal cream (estrogen) to treat GSM for 3 months. Application will be 1 g daily for the first two weeks. Afterwards, a maintenance dosage of 1 g three times a week is applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide informed consent
- Confirmed postmenopausal age
- Diagnosed genitourinary syndrome of menopause
- Access to a smartphone, tablet or computer, and to a functional email address.
Key exclusion criteria (4 listed)
- Contraindication for the use of estrogen therapy
- Unable to provide informed consent
- Patient unable to apply topical device
- Allergy or intolerance to ingredients or excipients of the formulation of studied products
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 |
|---|---|---|
| StrataMGTStrataMGT is a 100% medical grade film-forming silicone gel for the treatment of cutaneous skin lesions and Genitourinary Syndrome of Menopause. StrataMGT is a flexible wound dressing used on compromised skin. It dries to form a thin, flexible wound dressing which hydrates and protects affected areas. StrataMGT is used to relieve low grade inflammatory changes such as dry, itching, flaking, peeling and irritated skin. StrataMGT is designed for partially epithelized skin and is suitable for children and patients with sensitive skin. | Device | StrataMGT |
| Estrace 0.01% Vaginal CreamEstrace is a prescriptive female hormone indicated in the treatment of moderate to severe symptoms of Genitourinary Syndrome of Menopause. | Drug | Estrace |
Primary outcome
PROM: Quality of Life
Time frame: 3 months
The improvement of patient quality of life will be assessed at baseline and during each monthly follow-up using the patient-rated Vulvar Disease Quality of Life (VQLI) Index questionnaire. Questions are rated on a numeric scale from 0 (not at all) - 3 (very much). This outcome is patient-rated, thus unblinded.
7 secondary outcomes
Clinical signs
Time frame: 3 months
Adverse Reactions
Time frame: 3 months
Visual pathology
Time frame: 3 months
PROM: Symptoms
Time frame: 3 months
PROM: Dyspareunia
Time frame: 3 months
PROM: Product Rating
Time frame: 3 months
PROM: Treatment Adherence
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StrataMGT and Estrace 0.01% Vaginal Cream in people with Genitourinary Syndrome of Menopause, run by Stratpharma AG at 3 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROM: Quality of Life (time frame: 3 months). 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 20 Feb 2026.