RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-04
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05672901

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide informed consent
  2. * Confirmed postmenopausal age
  3. * Diagnosed genitourinary syndrome of menopause
  4. * Access to a smartphone, tablet or computer, and to a functional email address.
  1. * Contraindication for the use of estrogen therapy
  2. * Unable to provide informed consent
  3. * Patient unable to apply topical device
  4. * Allergy or intolerance to ingredients or excipients of the formulation of studied products

Contacts and Locations

Study Locations (Sites)

Orange Coast Women's Medical Group
Laguna Hills, California, 92653
United States
Medcare Research
Miami, Florida, 33125
United States
Abba Medical Group
Miami, Florida, 33176
United States
One Health Research Clinic
Johns Creek, Georgia, 30097
United States

Collaborators and Investigators

Sponsor: Stratpharma AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04
Study Completion Date2025-11

Study Record Updates

Study Start Date2024-04-04
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Genitourinary Syndrome of Menopause