Actively Recruiting

Phase Not Applicable
Age: 40Years - 70Years
FEMALE
ID06962345

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.

Led by Mucosa Innovations, S.L. · Updated on 2026-03-30

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Mucosa Innovations, S.L.

Lead Sponsor

H

Hospital de La Luz

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the management of Genitourinary Syndrome of Menopause (GSM), a condition causing symptoms like vaginal atrophy that affects quality of life in postmenopausal women. This trial aims to assess the safety and effects of a new hormone-free gel called XCMIM20m applied topically to the vulvovaginal area. The study uses a patient-reported outcome measure called the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire to compare symptoms before and after treatment. Participants will apply 2 ml of the XCMIM20m gel daily, divided into two 1 ml doses taken about 12 hours apart, preferably morning and bedtime, for 8 weeks. The gel is manually applied to the vulvar area, including the vaginal opening, without an intravaginal applicator. Adverse effects like irritation or infections will be monitored and recorded throughout the study. Women will self-assess their symptoms using the DIVA questionnaire at the start and end of the 8-week treatment to evaluate changes in GSM symptoms and quality of life. Researchers will track any side effects and collect detailed information if any occur. The primary measurement is the change in symptom impact on quality of life after 8 weeks of using the gel, with additional focus on the most affected quality of life areas.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has at least one symptom of Genitourinary Syndrome of Menopause or vulvovaginal atrophy as shown by gynecological exam with Vaginal Health Index ≤15
  • Patient is postmenopausal with at least 1 year without a menstrual period
  • Patient feels her quality of life is affected by GSM symptoms
  • Patient is not currently being treated for any gynecological disease
  • Patient can understand and complete self-reported questionnaires
Not Eligible

You will not qualify if you...

  • Patients unwilling to complete questionnaires, especially those about sexual functioning
  • Use of oral hormone or estrogen receptor modulators in past 8 weeks, vaginal hormone products in past 4 weeks, or any GSM therapies including non-hormonal lubricants or moisturizers in past week
  • History of vulvar, vaginal, or cervical cancer
  • Previous radiotherapy to pelvic or genital area
  • Diseases affecting collagen production
  • Use of cytotoxic drugs causing tissue regeneration issues in past 6 months
  • Previous laser or radiofrequency treatment for genital atrophy or pelvic floor issues
  • Active urinary or genital infections
  • History of urinary system cancer
  • Severe stress urinary incontinence (Sandvik score ≥8)
  • Pelvic organ prolapse grade III or higher
  • Medical or surgical history preventing participation as judged by investigator
  • Any condition impairing understanding of study or procedures as judged by investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during a routine visit at a Women's Unit

Implementation

Duration - 8 weeks

Participants use a hormone-free vulvovaginal gel daily for 8 weeks to manage symptoms of Genitourinary Syndrome of Menopause. They self-assess their symptoms and quality of life using PROMs questionnaires at the start and end of this period.

2 visits (baseline and end of study) for questionnaire assessments

Trial Site Locations

Total: 1 location

1

Mucosa Innovations S.L.

Madrid, Madrid, Spain, 28023

Actively Recruiting

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Research Team

J

Jorge Rodríguez-Vilaboa

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society.

David J Portman, Margery L S Gass, Vulvovaginal Atrophy Terminology Consensus Conference Panel

https://pubmed.ncbi.nlm.nih.gov/25160739

Day-to-Day Impact of Vaginal Aging questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women.

Alison J Huang, Steven E Gregorich, Miriam Kuppermann...

https://pubmed.ncbi.nlm.nih.gov/24983271