Actively Recruiting
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
Led by Mucosa Innovations, S.L. · Updated on 2026-03-30
80
Participants Needed
1
Research Sites
151 weeks
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
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
Official Title
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has at least one symptom of GSM or vulvovaginal atrophy confirmed 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 under care for any gynecological disease
- Patient can understand and complete self-reported questionnaires
You will not qualify if you...
- Patient refuses to fill the questionnaire, especially sexual functioning questions
- Use of oral hormones or estrogen receptor modulators within past 8 weeks
- Use of vaginal hormonal products within past 4 weeks
- Use of any prescription or non-prescription GSM therapies, including vaginal lubricants or moisturizers within past week
- History of vulvar, vaginal, or cervical cancer
- Received radiotherapy in pelvic or genital area
- Has diseases affecting collagen production
- Use of cytotoxic drugs causing tissue damage within past 6 months
- Received laser or radiofrequency treatment for genital atrophy or pelvic floor dysfunction
- 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 study participation as judged by investigator
- Any condition impairing understanding or following study procedures as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mucosa Innovations S.L.
Madrid, Madrid, Spain, 28023
Actively Recruiting
Research Team
J
Jorge Rodríguez-Vilaboa
CONTACT
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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