Clinical trial NCT06962345: Management of Genitourinary Syndrome of Menopause: Safety and Efficacy of a Novel Hormone-Free Vulvovaginal Gel and PROMs.
Official title: Management of Genitourinary Syndrome of Menopause With the Use of a Hormone-free Composition Vulvovaginal Gel and PROMs. Safety and Efficacy Pivotal Phase 2 Interventional, Longitudinal, Clinical Trial. Part of STOP GSM PROJECT (STOPGSMP).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvar Atrophy
Vulvovaginal Signs and Symptoms
Genitourinary Syndrome of Menopause
Quality of Life
Menopause Related Conditions
Dyspareunia
Urinary Incontinence, Urgency-frequency
Sexual Function
Women´s Health
Vaginal Dryness
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
Lead sponsor: Mucosa Innovations, S.L.
Sponsor class: INDUSTRY
Collaborators: name: Hospital de La Luz
name: Hospital Universitario Fundación Jiménez Díaz
First posted: 2025-05-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) and assess safety and efficacy of a novel hormone-free mucosa composition (XCM® INTIM) 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 efficacy and safety.

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 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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Changes in GSM symptoms impact on quality of life domains after the intervention
timeFrame: Eight weeks of use of the tested product.
measure: Changes in 23 items related to GSM symptoms impact on quality of life after the intervention
timeFrame: Eight weeks of use of the tested product.
Secondary outcomes:
measure: Changes in the most affected women's quality of life domain after the intervention
timeFrame: Eight weeks of use of the tested product.
Other outcomes:
measure: Adherence/compliance to the treatment
timeFrame: Eight weeks of use of the tested product.
Locations:
city: Madrid
country: Spain
facility: Mucosa Innovations S.L.
Study officials:
affiliation: Hospital La Luz
name: Manuel Albi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.