Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovagina… (NCT06962345) | Clinical Trial Compass
RecruitingNot Applicable
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
Spain80 participantsStarted 2024-01-08
Plain-language 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.
Who can participate
Age range
40 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in GSM symptoms impact on quality of life domains after the intervention
Timeframe: Eight weeks of use of the tested product.