Vulvar AtrophySTOPGSMPNCT06962345
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
A study testing Hormone-free vulvovaginal gel with the tested composition XCMIM20m in people with Vulvar Atrophy and Vulvovaginal Signs and Symptoms, run by Mucosa Innovations, S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause
- What is being tested?
- Hormone-free vulvovaginal gel with the tested composition XCMIM20m
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2024to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Mucosa Innovations S.L.
Madrid, Madrid, 28023
Jorge Rodríguez-Vilaboa, +34 629 288 597, jorge.vilaboa@mucosainnovations.com
About this study
Official title: Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial. Part of STOP GSM PROJECT.
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.
Read the 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 until today GSM is still hugely underreported, underdiscussed, underdiagnosed as well as undertreated.
Postmenopausal women suffering from symptoms of GSM will be recruited after a routine visit at a Women's Unit at a General Hospital. The participants will self-assess their symptoms with the use of the Day-to-Day impact of Vaginal Aging (DIVA) questionnaire at baseline and after 8 weeks of use of the tested product. Self-assessment with PROMs will allow to obtain a greater knowledge of the physical and emotional state of patients as well as to deliver valuable information to women.
Criteria for a successful outcome will be if the use of the hormone-free agent is well accepted and if symptoms and quality of life improve after 8 weeks of intervention.
Daily dosage of XCMIM20m ((2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid)) will be 2 ml of total product, divided in two applications of 1 ml every 12 hours, preferably morning and bedtime. To be spread topically onto the vulvar area, including the vaginal introitus. The gel will be further applied before sexual intercourse. No intravaginal applicator will be used as the agent will be manually applied directly onto the vulvar area from a 50 ml airless pump dispenser. Four pump applications from the pump dispenser are equivalent to 1ml of tested gel.
Adverse effects, such as allergic reaction, skin irritation, itching, discomfort, yeast infection, or any other, will be collected and if so, a detailed description and follow-up of the problem will be noted.
- Conditions
- Vulvar Atrophy, Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause, Quality of Life, Menopause Related Conditions, Dyspareunia
- Being tested
- Hormone-free vulvovaginal gel with the tested composition XCMIM20m
- Keywords
- Genitourinary Syndrome of Menopause, Vulvovaginal Signs and Symptoms, Patient Reported Outcome Measures, Quality of Life, Day-to-Day Impact of Vaginal Ageing, Women´s Health
- Medical subject headings
- Dyspareunia, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone-free vulvovaginal gel with the tested composition XCMIM20mDevice
Management of GSM in post-menopausal women will be measured with the combination of the application of the hormone-free vulvovaginal gel along the 8 weeks of the study and the use of a PROMs questionnaire. PROMS questionnaire will be delivered to the women at baseline and at the end of the study. Daily living quality of life domains of "activities of daily living", "emotional well-being", "sexual functioning", "self-perception and body image" will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with Genitourinary Syndrome of Menopause. | Experimental | Patients diagnosed with Genitourinary Syndrome of Menopause using a non-hormonal vulvovaginal gel with tested composition XCMIM20m and PROMs questionnaire. Receives: Device: Hormone-free vulvovaginal gel with the tested composition XCMIM20m |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in GSM symptoms impact on quality of life domains after the intervention
Difference of magnitude of complaint by domain after 8 weeks of use of the tested product compared with baseline with the use of the PROMs questionnaire.
The PROMs questionnaire will be the 23-item DIVA questionnaire comprising four domain scales: activities of daily living; emotional well-being; sexual functioning; and self-concept and body image.
Each 23 items will be scored from 0 (meaning lowest impact/best quality of life) to 4 (meaning highest impact/worst quality of life).
Total scores domain by domain will be assessed by calculating the average of scores for each item; higher scores will be interpreted as greater impact of GSM symptoms on women's quality of life and adscribed to each domain.
Measured: Eight weeks of use of the tested product.
Secondary outcomes (1)
Changes in the most affected women's quality of life domain after the intervention
Comparison in number of answers obtained for each score (0 to 4), domain by domain, at baseline and after 8 weeks of the use of the tested product assessed by the PROMs questionnaire.
The PROMs questionnaire will be the 23-item DIVA questionnaire comprising four domain scales: activities of daily living; emotional well-being; sexual functioning; and self-concept and body image.
Each 23 items will be scored from 0 (meaning lowest impact/best quality of life) to 4 (meaning highest impact/worst quality of life).
Total scores domain by domain will be assessed by calculating the average of scores for each item; higher scores will be interpreted as greater impact of GSM symptoms on women's quality of life and adscribed to each domain.
Measured: Eight weeks of use of the tested product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start8 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vulvar AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mucosa Innovations, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital de La Luz, Hospital Universitario Fundación Jiménez Díaz
- Responsible party
- Sponsor
- Investigators
- Manuel Albi, MD, PhD, Principal investigator, Hospital La Luz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962345
- Sponsor's protocol ID
- STOPGSM01
- Acronym
- STOPGSMP
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Portman DJ, Gass ML; Vulvovaginal Atrophy Terminology Consensus Conference Panel. Genitourinary syndrome of menopause: new terminology for vulvovaginal atrophy from the International Society for the Study of Women's Sexual Health and the North American Menopause Society. Menopause. 2014 Oct;21(10):1063-8. doi: 10.1097/GME.0000000000000329.
PubMed 25160739Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
PubMed 23985562Huang AJ, Gregorich SE, Kuppermann M, Nakagawa S, Van Den Eeden SK, Brown JS, Richter HE, Walter LC, Thom D, Stewart AL. Day-to-Day Impact of Vaginal Aging questionnaire: a multidimensional measure of the impact of vaginal symptoms on functioning and well-being in postmenopausal women. Menopause. 2015 Feb;22(2):144-54. doi: 10.1097/GME.0000000000000281.
PubMed 24983271Moral E, Delgado JL, Carmona F, Caballero B, Guillan C, Gonzalez PM, Suarez-Almarza J, Velasco-Ortega S, Nieto C; as the writing group of the GENISSE study. Genitourinary syndrome of menopause. Prevalence and quality of life in Spanish postmenopausal women. The GENISSE study. Climacteric. 2018 Apr;21(2):167-173. doi: 10.1080/13697137.2017.1421921. Epub 2018 Feb 7.
PubMed 29411644