An observational study in Vulvar Atrophy, Vulvovaginal Signs and Symptoms and Genitourinary Syndrome of Menopause (GSM), sponsored by Mucosa Innovations, S.L.. Not yet recruiting at 1 site in Spain. Open to female participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Mucosa Innovations, S.L. · Observational
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.
Genitourinary Syndrome of Menopause (GSM) encompasses a constellation of vulvovaginal and urinary signs and symptoms associated with estrogen deficiency and the resulting thinning of the urogenital mucosa. These symptoms include vaginal dryness, dyspareunia, itching/burning, irritation, dysuria, urinary frequency and urgency, among others. GSM symptoms are typically chronic and, unlike vasomotor symptoms of menopause, tend to worsen over time.
GSM affects between 27% and 84% of postmenopausal women and remains a frequently underdiagnosed and consequently undertreated condition. This underdiagnosis is primarily related to insufficient physician-patient communication regarding the condition. Patients may not report symptoms because they consider them a normal consequence of aging or feel embarrassed, while healthcare professionals do not always actively inquire about them.
Furthermore, GSM symptoms have a variable impact on the quality of life of menopausal women and may significantly affect multiple aspects of patients' lives, including daily activities, self-esteem, intimate relationships, and psychological well-being. In routine clinical practice, there is often limited information regarding which symptoms patients perceive as most bothersome and which dimensions of quality of life are most affected. For this reason, and in line with the principles of Value-Based Healthcare, questionnaires assessing the impact of GSM on women's quality of life have increasingly been incorporated into clinical practice in recent years, with the aim of focusing healthcare activities on those that generate the most meaningful patient outcomes. One example is the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire, extensively used in the Women´s Health Unit of the Hospital Universitario La Luz Quirónsalud.
The usual management of women with GSM includes the use of topical agents aimed at improving symptoms, with or without local estrogen therapy. When estrogen use is contraindicated, or when patients prefer non-hormonal alternatives, hormone-free creams and gels are commonly recommended. XCM INTIM (a non-hormonal topical gel containing olive oil, betaine, and xylitol; Mucosa Innovations S.L.) is among these products.
This study aims to retrospectively describe the pattern of GSM symptoms and their impact on quality of life among postmenopausal women who used XCM INTIM gel. Additionally, when available data from medical records, healthcare professional notes, and/or patient-completed questionnaires collected as part of routine clinical practice permit, the study will explore symptom evolution and functional impact in women with sufficient follow-up (defined as documentation of at least 8 weeks of product use).
Real-world data (RWD) studies provide valuable complementary evidence to clinical trials by capturing the effectiveness and safety of treatments in routine clinical practice settings.
In this context, the present protocol describes a retrospective observational study in a cohort of menopausal women with GSM who attended the Women's Health Unit of Hospital Universitario La Luz Quirónsalud between January 2022 and April 2026. The study aims to characterize the most prevalent genitourinary symptoms, their severity, and their impact on quality of life, as well as evaluate their evolution following the use of XCM INTIM topical gel.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's planned enrollment of 100 is below the median of 165 across 30 observational studies indexed under Dyspareunia.
Browse Dyspareunia studies →Mucosa Innovations, S.L. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
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Postmenopausal women attended at the Department of Obstetrics and Gynecology of Hospital Universitario La Luz between January 2022 and April 2026, with at least one symptom of GSM documented in their medical records.
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Patients included in this retrospective data evaluation must have met all of the following criteria:
Exclusion Criteria:
Patients will be excluded from the study if any of the following conditions were present:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal women attended at the Department of Obstetrics and Gynecology of Hospital Universitario La Luz between January 2022 and April 2026, with at least one retrospectively documented symptom of GSM in their medical records and retrospectively documented use of the hormone-free vulvovaginal gel XCM INTIM for a minimum of 8 weeks.
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.
Change in the magnitude of quality of life-domain scores between baseline and at least week 8 after initiation of use of XCM INTIM will be assessed using a widely used PROM questionnaire. The PROM questionnaire will be the 23-item Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire comprising 4 domains: Activities of Daily Living, Emotional Well-being, Sexual Functioning, and Self-Concept and Body Image. Each item will be scored from 0 (lowest impact/best quality of life) to 4 (highest impact/worst quality of life). Domain scores will be calculated as the means of the corresponding item scores, with higher scores indicating greater impairment in quality of life.
Time frame: Baseline and at least 8 weeks of use of the tested product.
Frequency of GSM symptoms in postmenopausal women who had used the non-hormonal topical gel XCM INTIM for at least 8 weeks.
The frequency of GSM symptoms reported by postmenopausal women and documented in medical records, clinician notes, and/or patient questionnaires will be assessed when existing recorded data. Symptoms of interest will include dyspareunia, non-coital vulvovaginal discomfort or pain, vulvovaginal dryness, vulvovaginal itching and/or burning, urinary symptoms (frequency, urgency, dysuria, or burning during urination). For each symptom, frequency will be summarized as the number and percentage of participants reporting the symptom. Symptom prevalence will be evaluated at baseline and after at least 8 weeks of XCM INTIM use.
Time frame: Baseline and at least 8 weeks of use of the tested product.
Distribution and severity of the symptom associated with the highest level of discomfort (most bothersome/severe GSM symptom) at baseline.
The most bothersome symptom (MBS), if reported by the participant and/or if documented in the medical record, clinician notes, or patient questionnaires, will be identified and categorized (e.g., dyspareunia, non-coital vulvovaginal discomfort or pain, vulvovaginal dryness, vulvovaginal itching and/or burning, urinary symptoms). Symptom severity will be scored in a 1-3 scale (1: mild, 2: moderate, or 3: severe), according to the available clinical documentation. Results will be summarized as the number and percentage of participants for each symptom category and severity level.
Time frame: Baseline
Change in the severity of the symptom initially identified as the most bothersome after XCM use for at least 8 weeks.
Change in the magnitude of severity of the most bothersome symptom, if documented, between baseline and at least week 8 after initiation of use of XCM INTIM will be assessed. Symptom severity will be scored in a 1-3 scale (1: mild, 2: moderate, or 3: severe), according to the existing available clinical documentation.
Time frame: Baseline and at least 8 weeks of use of the tested product.
Adverse effects/events related to the use of the topical measure.
Number (percentage) of patients with grade 1-4 NCI-CTCAE adverse effects/events related to the topical measure will be collected from medical records, when available.
Time frame: From the beginning of XCM INTIM use through 30 days after completion of the 8-10-week use period.
Adherence to the use of the vulvovaginal gel
Adherence to XCM INTIM use will be assessed based on information documented in medical records, clinician notes, and/or patient-reported information. Participants will be classified as having either good adherence or poor adherence according to the available clinical documentation. Adherence will be rated as good or poor based on whether the participant had continued using the topical gel after completing the 8-week use period or not. Results will be summarized as the number and percentage of participants in each adherence category.
Time frame: From completion of at least 8 weeks of XCM INTIM use onward.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Mucosa Innovations, S.L.