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

Study Overview
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Brief Summary
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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
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Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial

Conditions
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Genitourinary Syndrome of Menopause

Intervention / Treatment
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* Device: StrataMGT
* Drug: Estrace 0.01% Vaginal Cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StrataMGT<br>Participants will apply StrataMGT (silicone gel) 2-5 times daily (no limit in application times) to treat GSM for 3 months. | Device: StrataMGT<br>* 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.<br>|
| Active Comparator: Estrace<br>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. | Drug: Estrace 0.01% Vaginal Cream<br>* Estrace is a prescriptive female hormone indicated in the treatment of moderate to severe symptoms of Genitourinary Syndrome of Menopause.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROM: Quality of Life | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical signs | Signs are rated by the investigator (blinded) during baseline and at the final visit after 3 months, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. | 3 months | 
| Adverse Reactions | Adverse reactions are rated by the investigator (blinded) during baseline and at the final visit after 3 months, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. | 3 months | 
| Visual pathology | Severity of the visual pathology is rated by the investigator (blinded) during baseline and at the final visit after 3 months, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. | 3 months | 
| PROM: Symptoms | Symptoms are rated by the patient at baseline and during each monthly follow-up, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. This outcome is patient-rated, thus unblinded. | 3 months | 
| PROM: Dyspareunia | Dyspareunia is rated by the patient at baseline and during each monthly follow-up, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. This outcome is patient-rated, thus unblinded. | 3 months | 
| PROM: Product Rating | Product performance is rated by the patient at the final visit after 3 months, using a Likert scale from 1=unsatisfactory to 5=excellent. This outcome is patient-rated, thus unblinded. | 3 months | 
| PROM: Treatment Adherence | Treatment adherence is reported by the patient during the final study assessment, indicating the number of days/week and times/day the product was applied during the previous month. Percentage of treatment adherence is calculated from the minimum required treatment schedule. | 3 months |