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

Stratpharma AG · NCT05672901

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
100
US sites recruiting
3
Study start
April 4, 2023
Record last updated
February 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: StrataMGT; Estrace 0.01% Vaginal Cream

Conditions: Genitourinary Syndrome of Menopause

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Orange Coast Women's Medical Group

    Laguna Hills, CA 92653

    Site contact: Ellen Winter · +1 949 829 5500 · ellenmwinter@gmail.com

  • Abba Medical Group

    Miami, FL 33176

    Site contact: Dr. Jorge Fernandez · 786-353-2536 · mc@abbamedicalresearch.com

  • One Health Research Clinic

    Johns Creek, GA 30097

    Site contact: David Montaldi, DO · 678-585-4917 · sylvia@ohrclinic.com

All women’s health studies in California →
Silicone Gel vs. Estrogen Vaginal Cream for the Management of… (NCT05672901) | Bored Studies