Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause (VITAL-E)
Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause (VITAL-E)
ClinicalTrials.gov ID: NCT05672901
Sponsor: Stratpharma AG
Information provided by: Stratpharma AG (Responsible Party)
Last Update Posted: 2023-04-07
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.
Official Title:
Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial
Intervention / Treatment:
- Device: StrataMGT
- Drug: Estrace 0.01% Vaginal Cream
| Category | Value |
|---|---|
| Study Start (Actual) | 2023-03-27 |
| Primary Completion (Estimated) | 2024-06 |
| Study Completion (Estimated) | 2024-06 |
| Enrollment (Estimated) | 100 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
SPAMG02
|