An interventional study of Hormone-free vulvovaginal gel with the tested composition XCMIM20m in Vulvar Atrophy, Vulvovaginal Signs and Symptoms and Genitourinary Syndrome of Menopause, sponsored by Mucosa Innovations, S.L.. Recruiting at 1 site in Spain. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Mucosa Innovations, S.L. · Not applicable, Interventional, and Treatment
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.
The high prevalence of the Genitourinary Syndrome of the Menopause (GSM) previously known as vulvovaginal atrophy, atrophic vaginitis or urogenital atrophy, does not correlate with the fact that up until today GSM is still hugely underreported, underdiscussed, underdiagnosed as well as undertreated.
Postmenopausal women suffering from symptoms of GSM will be recruited after a routine visit at a Women's Unit at a General Hospital. The participants will self-assess their symptoms with the use of the Day-to-Day impact of Vaginal Aging (DIVA) questionnaire at baseline and after 8 weeks of use of the tested product. Self-assessment with PROMs will allow to obtain a greater knowledge of the physical and emotional state of patients as well as to deliver valuable information to women.
Criteria for a successful outcome will be if the use of the hormone-free agent is well accepted and if symptoms and quality of life improve after 8 weeks of intervention.
Daily dosage of XCMIM20m ((2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid)) will be 2 ml of total product, divided in two applications of 1 ml every 12 hours, preferably morning and bedtime. To be spread topically onto the vulvar area, including the vaginal introitus. The gel will be further applied before sexual intercourse. No intravaginal applicator will be used as the agent will be manually applied directly onto the vulvar area from a 50 ml airless pump dispenser. Four pump applications from the pump dispenser are equivalent to 1ml of tested gel.
Adverse effects, such as allergic reaction, skin irritation, itching, discomfort, yeast infection, or any other, will be collected and if so, a detailed description and follow-up of the problem will be noted.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's planned enrollment of 80 is above the median of 63 across 126 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Mucosa Innovations, S.L. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with Genitourinary Syndrome of Menopause using a non-hormonal vulvovaginal gel with tested composition XCMIM20m and PROMs questionnaire.
Device: Hormone-free vulvovaginal gel with the tested composition XCMIM20m
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.
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.
Time frame: Eight weeks of use of the tested product.
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.
Time frame: Eight weeks of use of the tested product.
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.
Time frame: Eight weeks of use of the tested product.
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.
Time frame: Eight weeks of use of the tested product
Plan to share: No
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Mucosa Innovations, S.L.