Silicone Gel Vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause (VITAL-E)

Stratpharma

Status: Enrolling

Conditions: Genitourinary Syndrome of Menopause

Treatments: Drug: Estrace 0.01% Vaginal Cream; Device: StrataMGT

Study type: Interventional

Funder types: Industry

Identifiers

NCT05672901

SPAMG02

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

StrataMGT

Experimental group

Description:

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

Treatment:

Device: StrataMGT

Estrace

Active Comparator group

Description:

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.

Treatment:

Drug: Estrace 0.01% Vaginal Cream