Genitourinary Syndrome of Menopause Clinical Trial
— VITAL-EOfficial title:
Comparison of a Novel Silicone Gel vs. Estrogen Vaginal Cream for the Management of Genitourinary Syndrome of Menopause: a Non-inferiority Trial
NCT number | NCT05672901 |
Other study ID # | SPAMG02 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 27, 2023 |
Est. completion date | June 2024 |
Verified date | January 2023 |
Source | Stratpharma AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Orange Coast Women's Medical Group | Laguna Hills | California |
Lead Sponsor | Collaborator |
---|---|
Stratpharma AG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PROM: Quality of Life | The improvement of patient quality of life will be assessed at baseline and during each monthly follow-up using the patient-rated Vulvar Disease Quality of Life (VQLI) Index questionnaire. Questions are rated on a numeric scale from 0 (not at all) - 3 (very much). This outcome is patient-rated, thus unblinded. | 3 months | |
Secondary | Clinical signs | Signs are rated by the investigator (blinded) during baseline and at the final visit after 3 months, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. | 3 months | |
Secondary | Adverse Reactions | Adverse reactions are rated by the investigator (blinded) during baseline and at the final visit after 3 months, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. | 3 months | |
Secondary | Visual pathology | Severity of the visual pathology is rated by the investigator (blinded) during baseline and at the final visit after 3 months, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. | 3 months | |
Secondary | PROM: Symptoms | Symptoms are rated by the patient at baseline and during each monthly follow-up, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. This outcome is patient-rated, thus unblinded. | 3 months | |
Secondary | PROM: Dyspareunia | Dyspareunia is rated by the patient at baseline and during each monthly follow-up, using a combination of visual assessment and categorical scale ranging from 0=normal to 10=worst possible. This outcome is patient-rated, thus unblinded. | 3 months | |
Secondary | PROM: Product Rating | Product performance is rated by the patient at the final visit after 3 months, using a Likert scale from 1=unsatisfactory to 5=excellent. This outcome is patient-rated, thus unblinded. | 3 months | |
Secondary | PROM: Treatment Adherence | Treatment adherence is reported by the patient during the final study assessment, indicating the number of days/week and times/day the product was applied during the previous month. Percentage of treatment adherence is calculated from the minimum required treatment schedule. | 3 months |
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