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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStratpharma AG

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • StrataMGT
  • Estrace 0.01% Vaginal Cream

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators