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

Study acronym: STOPGSMP
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion pushed from Dec 17, 2024 to Dec 2026
    • Study completion pushed from Dec 27, 2024 to Dec 2026
    • Trial status: Completed to Recruiting
    • Site details revised
    v8
  2. Study title shortened, about 1 wordv7
  3. Re-verified, no change to tracked fieldsv6
  4. Interventions: Hormone-free vulvovaginal gel with tested composition XCM® INTIM and PROMs questionnaire. (Device) to Hormone-free vulvovaginal gel with the tested composition XCMIM20m (Device)
    • Study description expanded, about 16 words
    • Study title expanded, about 2 words
    v5
  5. Primary endpoints: 2 to 1v4
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  1. Primary completion date: May 17, 2024 to Dec 17, 2024
    • Primary endpoints revised (2)
    • Study completion date: May 27, 2024 to Dec 27, 2024
    • Secondary endpoints: details revised at 1 of 1 entry
    v3
  2. Study title shortened, about 7 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06962345
Lead Sponsor Mucosa Innovations, S.L.
Collaborators: Hospital de La Luz, Hospital Universitario Fundación Jiménez Díaz
Conditions
(from sponsor)		 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
Related terms Dyspareunia, Urinary Incontinence
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov