Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM (NCT04746456) | Clinical Trial Compass
CompletedNot Applicable
Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM
United States210 participantsStarted 2022-09-01
Plain-language summary
The goal of this study is to perform a quantitative assessment of the psychometric properties of the Vulvovaginal Atrophy Questionnaire (VVAQ), a novel patient reported outcome measure (PROM), through a REDCap survey of menopausal women with and without symptomatic vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM).
Who can participate
Age range45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female
* Age \> 45 years
* Menopausal, defined as: \> 1 year since last menses (with a uterus, without progestin- releasing IUD, without prior endometrial ablation), or \> 6 months since bilateral oophorectomy
* Pelvic exam completed as part of visit
* Able to communicate in English
Exclusion Criteria:
* Chronic, bothersome vaginal symptoms before menopause (e.g. vulvar or vaginal pain, dryness, itching, discharge, discomfort with sexual activity)
* History of chronic urogenital condition (vulvar, vaginal, urinary), involving pain, pruritis, discharge, or inflammation, unrelated to menopausal estrogen deficiency
* History of lichen sclerosis or lichen planus
* History of vulvar, vaginal or cervical cancer
* Prior vulvar or vaginal surgery (office biopsy allowed)
* Active major medical illness (e.g., unstable heart disease, untreated psychiatric disorder) that might interfere with the ability to participate in the study
* Undiagnosed vaginal bleeding
* Exam findings consistent with a urogenital condition unrelated to menopausal estrogen deficiency (e.g. yeast or BV vaginitis, vulvodynia, vulvo-vestibulitis, lichen sclerosis, lichen planus)
What they're measuring
1
Responses to VVAQ and additional relevant questionnaires