Clinical Trial

Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.

Study acronym: STOPGSMP
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2024-12-17 -> 2026-12 2026-03-31
minor Completion pushed: 2024-12-27 -> 2026-12 2026-03-31
Trial Details
NCT Number NCT06962345
Lead Sponsor Mucosa Innovations, S.L.
Collaborators: Hospital de La Luz, Hospital Universitario Fundación Jiménez Díaz
Conditions Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause, Quality of Life, Menopause Related Conditions, Dyspareunia, Urinary Incontinence, Urgency-frequency, Sexual Function +2 more
Enrollment 80 participants
Start Date 2024-01-08
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-30