Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: StrataMGT, Estrace 0.01% Vaginal Cream.
- Who it may be relevant to
- Registry conditions: Genitourinary Syndrome of Menopause. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial
Overview
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.
Interventions
- Device StrataMGT
StrataMGT is a 100% medical grade film-forming silicone gel for the treatment of cutaneous skin lesions and Genitourinary Syndrome of Menopause. StrataMGT is a flexible wound dressing used on compromised skin. It dries to form a thin, flexible wound dressing which hydrates and protects affected areas. StrataMGT is used to relieve low grade inflammatory changes such as dry, itching, flaking, peeling and irritated skin. StrataMGT is designed for partially epithelized skin and is suitable for child - Drug Estrace 0.01% Vaginal Cream
Estrace is a prescriptive female hormone indicated in the treatment of moderate to severe symptoms of Genitourinary Syndrome of Menopause.
Primary outcome measures
- PROM: Quality of Life [Time frame: 3 months]
Secondary outcome measures (7)
- Clinical signs [Time frame: 3 months]
- Adverse Reactions [Time frame: 3 months]
- Visual pathology [Time frame: 3 months]
- PROM: Symptoms [Time frame: 3 months]
- PROM: Dyspareunia [Time frame: 3 months]
- PROM: Product Rating [Time frame: 3 months]
- PROM: Treatment Adherence [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Able to provide informed consent
- Confirmed postmenopausal age
- Diagnosed genitourinary syndrome of menopause
- Access to a smartphone, tablet or computer, and to a functional email address.
Exclusion criteria
- Contraindication for the use of estrogen therapy
- Unable to provide informed consent
- Patient unable to apply topical device
- Allergy or intolerance to ingredients or excipients of the formulation of studied products
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Orange Coast Women's Medical Group — Laguna Hills
- Abba Medical Group — Miami
- One Health Research Clinic — Johns Creek
Identifiers
NCT: NCT05672901 · SPAMG02