Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-02-21 @ 7:13 AM
Study NCT ID:
NCT03770169
Status:
COMPLETED
Last Update Posted:
2019-10-28
First Post:
2018-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Patient Reported Outcome Measures for Use in Vulvodynia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056650', 'term': 'Vulvodynia'}], 'ancestors': [{'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2018-11-29', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of mVPAQ', 'timeFrame': '1 week', 'description': 'Cognitive debrief and usability through interviews and completion of an electronic diary'}, {'measure': 'Validation of mFSFI', 'timeFrame': '1 week', 'description': 'Cognitive debrief and usability through interviews and completion of an electronic diary'}, {'measure': 'Validation of Pain on Intercourse Numeric Rating Scale (NRS)', 'timeFrame': '1 week', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Vulvar pain NRS', 'timeFrame': '1 week', 'description': 'Assess understanding of the appropriateness of the vulvar pain NRS through interview and completion of an electronic diary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vulvodynia']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects referred by clinicians', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fluent in understanding, speaking and reading US-English\n* Have vulvodynia with pain for at least 6 months\n\nExclusion Criteria:\n\n* Clinically significant history of alcohol/drug abuse or dependence within the last 2 years'}, 'identificationModule': {'nctId': 'NCT03770169', 'briefTitle': 'Validation of Patient Reported Outcome Measures for Use in Vulvodynia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'Validation of Patient Reported Outcome Measures for Use in Vulvodynia', 'orgStudyIdInfo': {'id': 'D-FR-52120-252'}}, 'contactsLocationsModule': {'locations': [{'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Sexual Medicine', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Center for Vulvovaginal Disorders', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Omaha OB-GYN Associates, PC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Center for Vulvovaginal Disorders', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}