Validation of Patient Reported Outcome Measures for Use in Vulvodynia

Ipsen

Status: Completed

Conditions: Vulvodynia

Study type: Observational

Funder types: Industry

Identifiers

NCT03770169

D-FR-52120-252

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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