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.
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…
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