Management of Genitourinary Syndrome of Menopause: Safety and Efficacy of a Novel Hormone-Free Vulvovaginal Gel and PROMs.

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

January 8, 2024

Primary Completion Date

December 17, 2024

Study Completion Date

December 27, 2024

Conditions
Vulvar AtrophyVulvovaginal Signs and SymptomsGenitourinary Syndrome of MenopauseQuality of LifeMenopause Related ConditionsDyspareuniaUrinary Incontinence, Urgency-frequencySexual FunctionWomen´s HealthVaginal Dryness
Interventions
DEVICE

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

"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."

Trial Locations (1)

28023

Mucosa Innovations S.L., Madrid

Sponsors
All Listed Sponsors
collaborator

Hospital de La Luz

OTHER

collaborator

Hospital Universitario Fundación Jiménez Díaz

OTHER

lead

Mucosa Innovations, S.L.

INDUSTRY

NCT06962345 - Management of Genitourinary Syndrome of Menopause: Safety and Efficacy of a Novel Hormone-Free Vulvovaginal Gel and PROMs. | Biotech Hunter | Biotech Hunter