NCT06962345

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mucosa Innovations, S.L. · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Vulvar Atrophy
• Vulvovaginal Signs and Symptoms
• Genitourinary Syndrome of Menopause
• Quality of Life
• Menopause Related Conditions
• Dyspareunia
• Urinary Incontinence, Urgency-frequency
• Sexual Function
• Women´s Health
• Vaginal Dryness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-08
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-05-08
• Last updated: 2026-03-30

Locations

1 site across 1 country: Spain