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Validation of Patient Reported Outcome Measures for Use in Vulvodynia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770169
Recruitment Status : Completed
First Posted : December 10, 2018
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief 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

Condition or disease
Vulvodynia

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of Patient Reported Outcome Measures for Use in Vulvodynia
Actual Study Start Date : February 18, 2019
Actual Primary Completion Date : September 19, 2019
Actual Study Completion Date : September 19, 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects referred by clinicians
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770169


Locations
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United States, California
San Diego Sexual Medicine
San Diego, California, United States, 92120
United States, District of Columbia
Center for Vulvovaginal Disorders
Washington, District of Columbia, United States, 20037
United States, Nebraska
Omaha OB-GYN Associates, PC
Omaha, Nebraska, United States, 68130
United States, New York
The Center for Vulvovaginal Disorders
New York, New York, United States, 10036
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03770169    
Other Study ID Numbers: D-FR-52120-252
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vulvodynia
Vulvar Diseases