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NCT03770169 Clinical Trial

Validation of Patient Reported Outcome Measures for Use in Vulvodynia

Vulvodynia Clinical Trial

Official title:
Validation of Patient Reported Outcome Measures for Use in Vulvodynia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03770169
Other study ID # D-FR-52120-252
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 18, 2019
Est. completion date September 19, 2019

Study information
Verified date October 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 19, 2019
Est. primary completion date September 19, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Center for Vulvovaginal Disorders New York New York
United States Omaha OB-GYN Associates, PC Omaha Nebraska
United States San Diego Sexual Medicine San Diego California
United States Center for Vulvovaginal Disorders Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Validation of mVPAQ Cognitive debrief and usability through interviews and completion of an electronic diary 1 week
Primary Validation of mFSFI Cognitive debrief and usability through interviews and completion of an electronic diary 1 week
Primary Validation of Pain on Intercourse Numeric Rating Scale (NRS) 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 Vulvar pain NRS Assess understanding of the appropriateness of the vulvar pain NRS through interview and completion of an electronic diary 1 week
See also
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