Menopause Clinical Trial
Official title:
Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel Patient Reported Outcome Measure (PROM)
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).
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 45 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Shifren JL, Zincavage R, Cho EL, Magnavita A, Portman DJ, Krychman ML, Simon JA, Kingsberg SA, Rosen RC. Women's experience of vulvovaginal symptoms associated with menopause. Menopause. 2019 Apr;26(4):341-349. doi: 10.1097/GME.0000000000001275. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Responses to VVAQ and additional relevant questionnaires | Results of REDCap survey | Baseline |
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