Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulv
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 o
| Condition(s) | Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause, Quality of Life, Menopause Related Conditions, Dyspareunia, Urinary Incontinence, Urgency-frequency, Sexual Functi |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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. * All participants must be able to understand and to fill in the self-reported questionnaires. Exclusion Criteria: * 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 |
| Ages | 40 Years to 70 Years |
| Sex | Female |
| Lead sponsor | Mucosa Innovations, S.L. |
| Locations | Madrid, Madrid, Spain |
| Start date | 2024-01-08 |
| NCT ID | NCT06962345 |
| Official listing | https://clinicaltrials.gov/study/NCT06962345 |