What this trial studies
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 in scope
- Genitourinary Syndrome of Menopause
Interventions
- StrataMGT (Device) — 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…
- Estrace 0.01% Vaginal Cream (Drug) — Estrace is a prescriptive female hormone indicated in the treatment of moderate to severe symptoms of Genitourinary Syndrome of Menopause.
Who can join
Women only · Ages 18 Years and up
Inclusion criteria
- 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.
Exclusion criteria
- 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 wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Laguna Hills | California | Orange Coast Women's Medical Group | Recruiting |
| Miami | Florida | Abba Medical Group | Recruiting |
| Johns Creek | Georgia | One Health Research Clinic | Recruiting |
Status & timeline
- Overall status: Recruiting
- Study type: Interventional
- Phase: N/A
- Start date: 2023-04-04
- Primary completion: 2026-09
- Last update posted: 2026-02-20
- First posted: 2023-01-05
Sponsor & contact
Lead sponsor: Stratpharma AG (Industry)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- PROM: Quality of Life (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.
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT05672901 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.