Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome o… (NCT07737782) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Spain100 participantsStarted 2026-07
Plain-language summary
The goal of this clinical trial is to retrospectively identify the most prevalent symptoms of genitourinary syndrome of menopause (GSM) among postmenopausal women and to evaluate their impact on quality of life. Moreover, based on data collected from medical records and/or patient-reported questionnaires, if available data enable it, it will be assessed whether treatment with the topical vulvovaginal gel XCM INTIM for a minimum of 8 weeks results in changes in symptom severity and in the impact of these symptoms across different quality-of-life domains.
Who can participate
Age range
40 Years – 75 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:
Patients included in this retrospective data evaluation must have met all of the following criteria:
* Postmenopausal women (defined as at least 12 consecutive months of amenorrhea)
* Present at least one symptom of GSM documented in the medical record
* Evidence in the medical record that the patient had perceived the GSM symptom(s) as having an impact on her quality of life.
* Documentation in the medical record that the patient had initiated treatment with XCM INTIM, together with follow-up clinical data including an assessment performed at least 8 weeks after treatment initiation.
* Patients that had attended at the Department of Obstetrics and Gynecology of Hospital Universitario La Luz between January 2022 and April 2026, regardless of whether they had participated in another study during this period.
Exclusion Criteria:
Patients will be excluded from the study if any of the following conditions were present:
* Use of topical vulvovaginal hormonal products within 4 weeks prior to initiation of XCM INTIM treatment.
* Use of systemic estrogen therapy within 8 weeks prior to initiation of XCM INTIM treatment.
* Presence of relevant gynecological and/or urinary conditions that could have interfered with the assessment of symptoms attributed to GSM, including but not limited to active vulvovaginal and/or urinary tract infections, significant vulvar lesions, active gynecological malignancies, severe stress urinary incontinence (Sandvik score ≥ 8), pel…
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
Change in the impact of GSM symptoms on quality-of-life domains, assessed via PROMs, in postmenopausal women who had used the non-hormonal topical gel XCM INTIM for at least 8 weeks.
Timeframe: Baseline and at least 8 weeks of use of the tested product.