๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โค15).
* 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.
๐
What it tests
- Hormone-free vulvovaginal gel with the tested composition XCMIM20m
Mucosa Innovations S.L.
Madrid, Spain
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.