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

Not Applicable

Recruiting

• Conditions: Genitourinary Syndrome of Menopause
• Interventions: Device: StrataMGT; Drug: Estrace 0.01% Vaginal Cream

• Registration Number: NCT05672901
• Lead Sponsor: Stratpharma AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Study Start: 2023-04-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
StrataMGT	StrataMGT	Participants will apply StrataMGT (silicone gel) 2-5 times daily (no limit in application times) to treat GSM for 3 months.
Estrace	Estrace 0.01% Vaginal Cream	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 Measures

Name	Time	Method
PROM: Quality of Life	3 months	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.

Secondary Outcome Measures

Name	Time	Method
PROM: Symptoms	3 months	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.
PROM: Treatment Adherence	3 months	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.
Clinical signs	3 months	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.
PROM: Dyspareunia	3 months	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.
Adverse Reactions	3 months	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.
Visual pathology	3 months	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.
PROM: Product Rating	3 months	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.

Trial Locations

Locations (3)

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