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

Study acronym: VITAL-E
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 20, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Nov 2025 to Sep 2026
    • Site contacts updated at 1 of 3 sites
    v6
  2. Study sites: 4 to 3
    • Start date: Apr 4, 2024 to Apr 4, 2023
    v5
  3. Primary and study completion dates: Jun 2024 to Nov 2025
    • Start date: Mar 27, 2023 to Apr 4, 2024
    • Study sites: 1 to 4
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to Mar 27, 2023
    • Site details revised
    v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05672901
Lead Sponsor Stratpharma AG
Conditions
(from sponsor)		 Genitourinary Syndrome of Menopause
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov