The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.
Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15).
Patient must be postmenopausal with at least 1 year without a menstrual period.
Patient must consider that her quality of life is affected by GSM symptoms
Patient not followed due to any gynecological disease.
Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning.
Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies for GSM, including topical vaginal non-hormonal lubricants or moisturizers for the last week.
Patients with history of vulvar, vaginal and/or cervical malignancy.
Patients having received radiotherapy treatment in the pelvic and/or genital region.
Mucosa Innovations, S.L.
Lead sponsor
Hospital de La Luz
Collaborator
Hospital Universitario Fundación Jiménez Díaz
Collaborator