Validation of Patient Reported Outcome Measures for Use in Vulvodynia

NCT ID: NCT03770169

Last Updated: 2019-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-18

Study Completion Date

2019-09-19

Brief Summary

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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

Detailed Description

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Conditions

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Vulvodynia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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San Diego Sexual Medicine

San Diego, California, United States

Site Status

Center for Vulvovaginal Disorders

Washington D.C., District of Columbia, United States

Site Status

Omaha OB-GYN Associates, PC

Omaha, Nebraska, United States

Site Status

The Center for Vulvovaginal Disorders

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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D-FR-52120-252

Identifier Type: -

Identifier Source: org_study_id

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