Silicone Gel Vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause
NCT ID: NCT05672901
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-04-04
2025-11-30
Brief Summary
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\- 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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StrataMGT
Participants will apply StrataMGT (silicone gel) 2-5 times daily (no limit in application times) to treat GSM for 3 months.
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 children and patients with sensitive skin.
Estrace
Participants will receive Estrace vaginal cream (estrogen) to treat GSM for 3 months. Application will be 1 g daily for the first two weeks. Afterwards, a maintenance dosage of 1 g three times a week is applied.
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.
Interventions
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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 children and patients with sensitive skin.
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.
Eligibility Criteria
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Inclusion Criteria
* Confirmed postmenopausal age
* Diagnosed genitourinary syndrome of menopause
* Access to a smartphone, tablet or computer, and to a functional email address.
Exclusion Criteria
* Unable to provide informed consent
* Patient unable to apply topical device
* Allergy or intolerance to ingredients or excipients of the formulation of studied products
18 Years
FEMALE
No
Sponsors
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Stratpharma AG
INDUSTRY
Responsible Party
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Locations
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Orange Coast Women's Medical Group
Laguna Hills, California, United States
Abba Medical Group
Miami, Florida, United States
One Health Research Clinic
Johns Creek, Georgia, United States
Countries
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Facility Contacts
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Ellen Winter
Role: primary
Marc Winter, M.D.
Role: backup
Dr. Jorge Fernandez
Role: primary
David Montaldi, DO
Role: primary
Other Identifiers
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SPAMG02
Identifier Type: -
Identifier Source: org_study_id