Status:
COMPLETED
Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Vulvovaginal Atrophy
Menopause
Eligibility:
FEMALE
45+ years
Brief 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...
Detailed Description
Bothersome vaginal dryness, dyspareunia, urinary symptoms, and related sexual and quality of life sequelae are common problems for women during and after the menopausal transition. These genitourinary...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2024
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04746456
Start Date
September 1 2022
End Date
May 1 2024
Last Update
May 30 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114