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

NCT04746456 | Completed

• 1 other identifier: 2020P003777
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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 a REDCap survey of menopausal women with and without symptomatic vulvovaginal atrophy (VVA)/genitourinary syndrome of menopause (GSM).

Conditions

Vulvovaginal Atrophy; Menopause; Genitourinary Syndrome of Menopause

Keywords

Vulvovaginal atrophy; Menopause; Genitourinary Syndrome of Menopause; Patient Reported Outcome Measure (PROM)

Outcome Measures

Primary Outcomes (1)

• Responses to VVAQ and additional relevant questionnaires

  Results of REDCap survey

  Baseline

Study Arms (1)

Menopausal women

Women will complete a series of questionnaires, including the VVAQ

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is an observational psychometric validation study through a REDCap survey of approximately 200 menopausal women age 45 years or older with and without symptomatic VVA/GSM. No medications or treatments will be administered.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 30531443 BACKGROUND

Study Officials

• Jan Shifren, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Midlife Women's Health Center, Dept. Ob/Gyn

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 9, 2021
• Study Start: September 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

US (1)