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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Orange Coast Women's Medical Group
RECRUITING
Laguna Hills
Florida
Abba Medical Group
RECRUITING
Miami
Georgia
One Health Research Clinic
RECRUITING
Johns Creek
Time Frame
Start Date: 2023-04-04
Estimated Completion Date: 2026-09
Participants
Target number of participants: 100
Treatments
Experimental: StrataMGT
Participants will apply StrataMGT (silicone gel) 2-5 times daily (no limit in application times) to treat GSM for 3 months.
Active_comparator: Estrace
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.
Related Therapeutic Areas
Sponsors
Leads: Stratpharma AG

This content was sourced from clinicaltrials.gov