Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause

Part of paid clinical trials in Laguna Hills, California.

Sponsor
Stratpharma AG
Study ID
NCT05672901
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • StrataMGT — DEVICE
    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 — DRUG
    Estrace is a prescriptive female hormone indicated in the treatment of moderate to severe symptoms of Genitourinary Syndrome of Menopause.

Study Details

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.

Key Dates

Start date
Apr 4, 2023
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: StrataMGT
    Participants will apply StrataMGT (silicone gel) 2-5 times daily (no limit in application times) to treat GSM for 3 months.
  • Active Comparator: 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.

Primary Outcome Measure

PROM: Quality of Life [ Time Frame: 3 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Orange Coast Women's Medical GroupLaguna HillsCalifornia92653
Ellen Winter
[email protected]
+1 949 829 5500
Marc Winter, M.D. (PRINCIPAL_INVESTIGATOR)
Abba Medical GroupMiamiFlorida33176
Dr. Jorge Fernandez
[email protected]
786-353-2536
One Health Research ClinicJohns CreekGeorgia30097
David Montaldi, DO
[email protected]
678-585-4917

Find similar trials in Laguna Hills, CA

By condition
Menopause
By specialty
Women's healthFertility
By research site
Orange Coast Women's Medical Group· Laguna Hills, CAAbba Medical Group· Miami, FLOne Health Research Clinic· Johns Creek, GA

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