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

NCT06962345 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-30

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • Hospital de La Luz

    collaborator OTHER

  • Hospital Universitario Fundación Jiménez Díaz

    collaborator OTHER

  • Mucosa Innovations, S.L.

    lead INDUSTRY

Principal Investigators

  • Manuel Albi, MD, PhD · Hospital La Luz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06962345 on ClinicalTrials.gov