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

Recruiting N/A Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 – 70
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Mucosa Innovations, S.L. · Industry
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About This Trial
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…
Trial Locations
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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…
Contacts

Jorge Rodríguez-Vilaboa

+34 629 288 597

jorge.vilaboa@mucosainnovations.com

CONTACT