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Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause — VITAL-E  

Genitourinary Syndrome of Menopause Clinical Trial

Official title:
Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial

Clinical 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? 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Genitourinary Syndrome of Menopause
  • Syndrome
Clinical Trial Details
NCT number NCT05672901
Study type Interventional
Source Stratpharma AG
Contact
Status Recruiting
Phase N/A
Start date March 27, 2023
Completion date June 2024
View Details
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