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.
Single group
Hormone-free vulvovaginal gel with the tested composition XCMIM20m
DeviceManagement 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.
Changes in GSM symptoms impact on quality of life domains after the intervention
Difference of magnitude of complaint by domain after 8 weeks of use of the tested product compared with baseline with the use of the PROMs questionnaire. The PROMs questionnaire will be the 23-item DIVA questionnaire comprising four domain scales: activities of daily living; emotional well-being; sexual functioning; and self-concept and body image. Each 23 items will be scored from 0 (meaning lowest impact/best quality of life) to 4 (meaning highest impact/worst quality of life). Total scores domain by domain will be assessed by calculating the average of scores for each item; higher scores will be interpreted as greater impact of GSM symptoms on women's quality of life and adscribed to each domain.
Changes in the most affected women's quality of life domain after the intervention
Comparison in number of answers obtained for each score (0 to 4), domain by domain, at baseline and after 8 weeks of the use of the tested product assessed by the PROMs questionnaire. The PROMs questionnaire will be the 23-item DIVA questionnaire comprising four domain scales: activities of daily living; emotional well-being; sexual functioning; and self-concept and body image. Each 23 items will be scored from 0 (meaning lowest impact/best quality of life) to 4 (meaning highest impact/worst quality of life). Total scores domain by domain will be assessed by calculating the average of scores for each item; higher scores will be interpreted as greater impact of GSM symptoms on women's quality of life and adscribed to each domain.
Adherence/compliance to the treatment
Adherence/compliance will be rated as good or poor. Adherence/compliance will be considered Good when the participant finishes the study period and fills in the second DIVA Questionnaire, and asks for extra product refill during the intervention and/or at the end of the intervention period. Adherence/compliance will be considered Poor when the participant does not finish the study period and/or does not fill in the second DIVA Questionnaire, and/or does not ask for any extra product refill during the intervention and/or at the end of the intervention period.
Changes in 23 items related to GSM symptoms impact on quality of life after the intervention
Difference of intensity of each 23 complaints after 8 weeks of use of the tested product compared with baseline as described in the PROMs questionnaire. The PROMs questionnaire will be the 23-item DIVA questionnaire comprising four domain scales: activities of daily living; emotional well-being; sexual functioning; and self-concept and body image. Each 23 items will be scored from 0 (meaning lowest impact/best quality of life) to 4 (meaning highest impact/worst quality of life). Higher complaint scores will be interpreted as greater impact of GSM symptoms on women's quality of life.
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Mucosa Innovations, S.L.
Lead sponsor
Hospital de La Luz
Collaborator
Hospital Universitario Fundación Jiménez Díaz
Collaborator
