Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05672901

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

Led by Stratpharma AG · Updated on 2026-02-20

100

Participants Needed

3

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Orange Coast Women's Medical Group

Laguna Hills, California, United States, 92653

Actively Recruiting

2

Abba Medical Group

Miami, Florida, United States, 33176

Actively Recruiting

3

One Health Research Clinic

Johns Creek, Georgia, United States, 30097

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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