Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.

NCT06962345 | Recruiting

• 1 other identifier: STOPGSM01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Genitourinary Syndrome of Menopause; Quality of Life; Menopause Related Conditions; Dyspareunia; Urinary Incontinence, Urgency-frequency; Sexual Function; Women´s Health; Vaginal Dryness; Vulvar Atrophy; Vulvovaginal Signs and Symptoms

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Eight weeks of use of the tested product.

Other Outcomes (2)

• Adherence/compliance to the treatment

  Eight weeks of use of the tested product.

• Changes in 23 items related to GSM symptoms impact on quality of life after the intervention

  Eight weeks of use of the tested product

Study Arms (1)

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.

Device: Hormone-free vulvovaginal gel with the tested composition XCMIM20m

Interventions

Hormone-free vulvovaginal gel with the tested composition XCMIM20m DEVICE

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.

Patients diagnosed with Genitourinary Syndrome of Menopause.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mucosa Innovations, S.L.: lead
• Hospital de La Luz: collaborator
• Hospital Universitario Fundación Jiménez Díaz: collaborator

Study Sites (1)

Mucosa Innovations S.L.

Madrid, Madrid, 28023, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 25160739 BACKGROUND

• Management 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.

  PMID: 23985562 BACKGROUND

• Huang 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.

  PMID: 24983271 BACKGROUND

• Moral 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.

  PMID: 29411644 BACKGROUND

MeSH Terms

Conditions

Dyspareunia; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Albi, MD, PhD

  Hospital La Luz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Rodríguez-Vilaboa

CONTACT

+34 629 288 597; jorge.vilaboa@mucosainnovations.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: January 8, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)