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

Description

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.

Conditions

Genitourinary Syndrome of Menopause

Study Overview

Study Details

Study overview

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.

Comparison of a Novel Silicone Gel Vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial

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

Condition
Genitourinary Syndrome of Menopause
Intervention / Treatment

-

Contacts and Locations

Laguna Hills

Orange Coast Women's Medical Group, Laguna Hills, California, United States, 92653

Miami

Medcare Research, Miami, Florida, United States, 33125

Miami

Abba Medical Group, Miami, Florida, United States, 33176

Johns Creek

One Health Research Clinic, Johns Creek, Georgia, United States, 30097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stratpharma AG,

Study Record Dates

2025-11