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

Last updated: December 6, 2024
Sponsor: Stratpharma AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Atrophy

Treatment

Estrace 0.01% Vaginal Cream

StrataMGT

Clinical Study ID

NCT05672901
SPAMG02
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 studiedproducts

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Estrace 0.01% Vaginal Cream
Phase:
Study Start date:
April 04, 2023
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Orange Coast Women's Medical Group

    Laguna Hills, California 92653
    United States

    Active - Recruiting

  • Abba Medical Group

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Medcare Research

    Miami, Florida 33125
    United States

    Site Not Available

  • One Health Research Clinic

    Johns Creek, Georgia 30097
    United States

    Active - Recruiting

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