NCT05672901 Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause
| NCT ID | NCT05672901 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stratpharma AG |
| Condition | Genitourinary Syndrome of Menopause |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-04-04 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-04-04 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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? 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05672901 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Genitourinary Syndrome of Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05672901 currently recruiting?
Yes, NCT05672901 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stratpharma AG to inquire about joining.
Where is the NCT05672901 trial being conducted?
This trial is being conducted at Laguna Hills, United States, Miami, United States, Johns Creek, United States.
Who is sponsoring the NCT05672901 clinical trial?
NCT05672901 is sponsored by Stratpharma AG. The trial plans to enroll 100 participants.