Management of Genitourinary Syndrome of Menopause: Safety and Efficacy of a Novel Hormone-Free Vulvovaginal Gel and PROMs. A Pivotal Phase 2 Interventional Clinical Trial.

Mucosa Innovations

Status: Completed

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

Treatments: Device: Hormone-free vulvovaginal gel with tested composition XCM® INTIM and PROMs questionnaire.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06962345

STOPGSM01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Patients diagnosed with Genitourinary Syndrome of Menopause.

Experimental group

Description:

Patients diagnosed with Genitourinary Syndrome of Menopause using a non-hormonal vulvovaginal gel with tested composition XCM® INTIM and PROMs questionnaire.

Treatment:

Device: Hormone-free vulvovaginal gel with tested composition XCM® INTIM and PROMs questionnaire.