Validation of Patient Reported Outcome Measures for Use in Vulvodynia

October 25, 2019 updated by: Ipsen
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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • San Diego Sexual Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Center for Vulvovaginal Disorders
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Omaha OB-GYN Associates, PC
    • New York
      • New York, New York, United States, 10036
        • The Center for Vulvovaginal Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subjects referred by clinicians

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of mVPAQ
Time Frame: 1 week
Cognitive debrief and usability through interviews and completion of an electronic diary
1 week
Validation of mFSFI
Time Frame: 1 week
Cognitive debrief and usability through interviews and completion of an electronic diary
1 week
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.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2019

Primary Completion (Actual)

September 19, 2019

Study Completion (Actual)

September 19, 2019

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-FR-52120-252

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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