Recruiting

Silicone Gel vs. Estrogen Cream

Sponsor:

Stratpharma AG

Code:

NCT05672901

Conditions

Genitourinary Syndrome of Menopause

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

StrataMGT

Estrace 0.01% Vaginal Cream

Study Details

Brief 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.

Conditions

Genitourinary Syndrome of Menopause

Study ID

NCT05672901

Start date

Apr 4, 2023

Status verified date

Feb, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 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 studied products

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

StrataMGT

StrataMGT is a 100% medical grade film-forming silicone gel for the treatment of cutaneous skin lesions and Genitourinary Syndrome of Menopause. StrataMGT is a flexible wound dressing used on compromised skin. It dries to form a thin, flexible wound dressing which hydrates and protects affected areas. StrataMGT is used to relieve low grade inflammatory changes such as dry, itching, flaking, peeling and irritated skin. StrataMGT is designed for partially epithelized skin and is suitable for children and patients with sensitive skin.

Estrace 0.01% Vaginal Cream

Estrace is a prescriptive female hormone indicated in the treatment of moderate to severe symptoms of Genitourinary Syndrome of Menopause.

Primary outcome measure

  • PROM: Quality of Life [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Orange Coast Women's Medical Group

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Ellen Winter

+1 949 829 5500ellenmwinter@gmail.com

Principal Investigator:

Marc Winter, M.D.

Abba Medical Group

Recruiting

Miami, Florida, United States, 33176

Contacts

Dr. Jorge Fernandez

786-353-2536mc@abbamedicalresearch.com

One Health Research Clinic

Recruiting

Johns Creek, Georgia, United States, 30097

Contacts

David Montaldi, DO

678-585-4917sylvia@ohrclinic.com

More Information

Sponsor

Stratpharma AG

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stratpharma AG on 2026-02-20.