Status
Completed
Phase
N/A
Study type
Observational
Enrollment
300
Sex
Women only
Ages
Ages 30 Years and up
Primary completion
2024-01-22
Last update
2025-11-26

What this trial studies

To determine the reliability and validity of the Portuguese version of the DIVA questionnaire in Portuguese women. This validation will support its use both in research and in routine clinical practice in this population.

Conditions in scope

  • Vulvovaginal Atrophy
  • Genital Disorder
  • PROMs

Interventions

  • Not specified in the public record.

Who can join

Women only · Ages 30 Years and up

Inclusion criteria

  • dryness
  • itching
  • irritation
  • discomfort on urination or during intercourse
  • pain on urination or during intercourse
  • bleeding during intercourse

Exclusion criteria

  • pregnancy
  • active cancer
  • inability to speak Portuguese
  • mental or physical condition that prevents providing coherent responses to the questionnaire.

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

Where it’s happening

CityState / RegionFacilitySite status
Lisbon Lisbon District Personalized Health Care Unit of Sete Rios Unknown

Status & timeline

  • Overall status: Completed
  • Study type: Observational
  • Phase: N/A
  • Start date: 2022-10-02
  • Primary completion: 2024-01-22
  • Last update posted: 2025-11-26
  • First posted: 2025-11-26

Lead sponsor: Instituto Politécnico de Leiria (Other)

Collaborators: Fundação para a Ciência e a Tecnologia, Hospital Santo André - Centro Hospitalar de Leiria, University of Minho

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

  • Psychometric validation of Day to Day Impact of Vaginal Ageing Questionnaire (DIVA) to Portuguese Woman from Portugal Country. The methodological approach is a descriptive cross-sectional study of qualitative and quantitative variables. (Each patient complete the five questionnaires at baseline and a subset of 50 patients were selected to repeat the DIVA questionnaire and the Symptoms questionnaire 2 to 30 days after baseline to access Test-retest reliability.)
    Primary outcome measure focuses on the psychometric validation of the portuguese version of the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire, including the evaluation of its internal consistency, factorial structure, construct validity, and test-retest reliability. The DIVA assesses the impact of vaginal aging symptoms in the daily activities, sexual function, emotional well-being, and self-concept/body image domains, with scores ranging from…

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.

Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT07250490 before contacting a site.

ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.