Clinical Trial

Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause

Study acronym: VITAL-E
Recruiting
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-01-03; most recent amendment 2026-02-19.
Status change: Not Yet Recruiting → Recruiting 2023-04-06
Trial Details
NCT Number NCT05672901
Lead Sponsor Stratpharma AG
Conditions Genitourinary Syndrome of Menopause
Enrollment 100 participants
Start Date 2023-04-04
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-02-20