Vulvovaginal Atrophy Questionnaire (VVAQ): Psychometric Validation of a Novel PROM

What this trial studies

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).

Conditions in scope

• Vulvovaginal Atrophy
• Menopause
• Genitourinary Syndrome of Menopause

Interventions

• Not specified in the public record.

Who can join

Women only · Ages 45 Years and up

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)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2022-09-01
• Primary completion: 2024-05-01
• Last update posted: 2025-05-30
• First posted: 2021-02-09

Sponsor & contact

Lead sponsor: Massachusetts General Hospital (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Responses to VVAQ and additional relevant questionnaires (Baseline)
  Results of REDCap survey

Related ClearedRx care

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