NCT06962345 Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
| NCT ID | NCT06962345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mucosa Innovations, S.L. |
| Condition | Vulvar Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-01-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15). * Patient must be postmenopausal with at least 1 year without a menstrual period. * Patient must consider that her quality of life is affected by GSM symptoms * Patient not followed due to any gynecological disease. * All participants must be able to understand and to fill in the self-reported questionnaires. Exclusion Criteria: * Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning. * Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies for GSM, including topical vaginal non-hormonal lubricants or moisturizers for the last week. * Patients with history of vulvar, vaginal and/or cervical malignancy. * Patients having received radiotherapy treatment in the pelvic and/or genital region. * Patients with any type of disease that causes alteration of collagenogenesis. * Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months. * Patients having received laser and/or radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions. * Patients with active urinary and/or genital tract infection. * Patients with history of malignant neoplasm of the urinary system. * Patients with severe stress urinary incontinence (Sandvik test score equal to or greater than 8). * Patients with diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification. * Patients with medical or surgery history that, at the investigator's discretion, does not allow participation in the study. * Patients with any other condition that, at the investigator's discretion, implies that the patient is unable to understand the implication of participating in the study and/or following the established procedures.
Contact & Investigator
Manuel Albi, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital La Luz
Frequently Asked Questions
Who can join the NCT06962345 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 70 Years, studying Vulvar Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06962345 currently recruiting?
Yes, NCT06962345 is actively recruiting participants. Contact the research team at jorge.vilaboa@mucosainnovations.com for enrollment information.
Where is the NCT06962345 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06962345 clinical trial?
NCT06962345 is sponsored by Mucosa Innovations, S.L.. The principal investigator is Manuel Albi, MD, PhD at Hospital La Luz. The trial plans to enroll 80 participants.