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OpenTrials
Completed

NCT Number: NCT03770169

Validation of Patient Reported Outcome Measures for Use in Vulvodynia

The overall aim of this project is to demonstrate content validity and usability of the modified Vulvar Pain Assessment Questionnaire (mVPAQ), the modified Female Sexual Function Index (mFSFI), and pain on intercourse Numeric Rating Scale (NRS) for adult patients with Vulvodynia

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Key information

Conditions

Vulvodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

San Diego Sexual Medicine, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fluent in understanding, speaking and reading US-English
  • Have vulvodynia with pain for at least 6 months

Exclusion criteria

  • Clinically significant history of alcohol/drug abuse or dependence within the last 2 years

Treatment and study plan

Primary outcomes

  1. Validation of mVPAQ

    Time frame: 1 week

    Cognitive debrief and usability through interviews and completion of an electronic diary

  2. Validation of mFSFI

    Time frame: 1 week

    Cognitive debrief and usability through interviews and completion of an electronic diary

  3. Validation of Pain on Intercourse Numeric Rating Scale (NRS)

    Time frame: 1 week

    Cognitive debrief and usability through interviews and completion of an electronic diary. Pain on Intercourse NRS that describes pain experienced during this sexual intercourse episode by number. The higher is the number the worse is pain.

Secondary outcomes

  1. Vulvar pain NRS

    Time frame: 1 week

    Assess understanding of the appropriateness of the vulvar pain NRS through interview and completion of an electronic diary

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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