Nonhormonal vulvovaginal gel to relieve menopausal vulvovaginal symptoms
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.
This will test a hormone-free vulvovaginal gel in postmenopausal women with genitourinary syndrome of menopause to see if it reduces vaginal atrophy symptoms and improves daily quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | Female |
| Sponsor | Mucosa Innovations, S.L. Industry-sponsored |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06962345 on ClinicalTrials.gov |
What this trial studies
Postmenopausal women with symptoms of GSM and a Vaginal Health Index ≤15 will apply a novel hormone-free gel (XCMIM20m) topically to the vulvar area, 1 mL twice daily, for 8 weeks. Participants will complete the Day-to-Day Impact of Vaginal Aging (DIVA) patient-reported outcome measure at baseline and after 8 weeks to capture symptom and quality-of-life changes. The trial excludes recent users of systemic or vaginal hormone therapies and topical vulvovaginal products to limit confounding. Safety, acceptability, and symptom change will be recorded to provide preliminary data on tolerability and potential effectiveness.
Who should consider this trial
Good fit: Postmenopausal women who have at least one GSM symptom, a Vaginal Health Index ≤15, and are not using systemic or topical hormone therapies would be ideal candidates.
Not a fit: Women with active gynecological disease, recent use of hormone or topical GSM therapies, or who are not experiencing GSM symptoms are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the gel could offer a hormone-free topical option that reduces GSM symptoms and improves day-to-day quality of life.
How similar studies have performed: Nonhormonal topical moisturizers and lubricants have shown modest symptomatic benefit in prior studies, but this specific XCMIM20m composition is novel and has limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid, Madrid
- Mucosa Innovations S.L. — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Manuel Albi, MD, PhD — Hospital La Luz
- Study coordinator: Jorge Rodríguez-Vilaboa
- Email: jorge.vilaboa@mucosainnovations.com
- Phone: +34 629 288 597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.