Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial. Part of STOP GSM PROJECT.
Mucosa Innovations, S.L.
80 participants
Jan 8, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria13
- 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.
- Patients with any type of disease that causes alteration of collagenogenesis.
- Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months.
- Patients having received laser and/or radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions.
- Patients with active urinary and/or genital tract infection.
- Patients with history of malignant neoplasm of the urinary system.
- Patients with severe stress urinary incontinence (Sandvik test score equal to or greater than 8).
- Patients with diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification.
- Patients with medical or surgery history that, at the investigator's discretion, does not allow participation in the study.
- Patients with any other condition that, at the investigator's discretion, implies that the patient is unable to understand the implication of participating in the study and/or following the established procedures.
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Interventions
Management of GSM in post-menopausal women will be measured with the combination of the application of the hormone-free vulvovaginal gel along the 8 weeks of the study and the use of a PROMs questionnaire. PROMS questionnaire will be delivered to the women at baseline and at the end of the study. Daily living quality of life domains of "activities of daily living", "emotional well-being", "sexual functioning", "self-perception and body image" will be evaluated.
Locations(1)
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NCT06962345