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NCT05672901 · ClinicalTrials.gov registry record · NA
Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause
A NA study of Genitourinary Syndrome of Menopause, sponsored by Stratpharma.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 3
- Study locations
NCT05672901: Recruiting NA study of Genitourinary Syndrome of Menopause, sponsored by Stratpharma.
NCT05672901 is a NA study of Genitourinary Syndrome of Menopause that is actively recruiting participants, run by Stratpharma. The registered enrollment target is 100 participants, below the 370-participant average among 6 other Genitourinary Syndrome of Menopause trials with a reported enrollment target (73% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05672901, a NA study of Genitourinary Syndrome of Menopause, is actively recruiting participants, sponsored by Stratpharma.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
The improvement of patient quality of life will be assessed at baseline and during each monthly follow-up using the patient-rated Vulvar Disease Quality of Life (VQLI) Index questionnaire. Questions are rated on a numeric scale from 0 (not at all) - 3 (very much). This outcome is patient-rated, thus unblinded.
Conditions Studied
Interventions
- DEVICE StrataMGT
- DRUG Estrace 0.01% Vaginal Cream
Study Locations (3)
California
- Orange Coast Women's Medical Group - Laguna Hills
Florida
- Abba Medical Group - Miami
Georgia
- One Health Research Clinic - Johns Creek
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2026-09 |
| Phase | NA |
What NCT05672901 shows while recruiting
NCT05672901 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 370-participant average among 6 other Genitourinary Syndrome of Menopause trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Genitourinary Syndrome of Menopause appearing as the primary indexed condition, and to 2 interventions - of which StrataMGT is the first listed.
NCT05672901 reports a single indexed study location in California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05672901 about?
NCT05672901 is a clinical study titled "Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause". 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 stan...
What is the current status of trial NCT05672901?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-04-04. Estimated completion is 2026-09.
What conditions does trial NCT05672901 study?
This clinical trial studies the following conditions: Genitourinary Syndrome of Menopause.
What interventions are being tested in trial NCT05672901?
The interventions under investigation include: StrataMGT (DEVICE), Estrace 0.01% Vaginal Cream (DRUG).
Who is sponsoring clinical trial NCT05672901?
This trial is sponsored by Stratpharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05672901 being conducted?
This trial has 3 study locations across California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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