Status:
COMPLETED
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
Lead Sponsor:
Mucosa Innovations, S.L.
Collaborating Sponsors:
Hospital de La Luz
Hospital Universitario Fundación Jiménez Díaz
Conditions:
Vulvar Atrophy
Vulvovaginal Signs and Symptoms
Eligibility:
FEMALE
40-70 years
Phase:
NA
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 (XCMIM...
Detailed Description
The high prevalence of the Genitourinary Syndrome of the Menopause (GSM) previously known as vulvovaginal atrophy, atrophic vaginitis or urogenital atrophy, does not correlate with the fact that up un...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06962345
Start Date
January 8 2024
End Date
December 27 2024
Last Update
January 2 2026
Active Locations (1)
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1
Mucosa Innovations S.L.
Madrid, Madrid, Spain, 28023