Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-27 @ 2:37 PM
Study NCT ID:
NCT01295268
Status:
TERMINATED
Last Update Posted:
2017-01-25
First Post:
2011-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Emu Oil vs. Placebo for Vulvar Pain in Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056650', 'term': 'Vulvodynia'}, {'id': 'D054515', 'term': 'Vulvar Vestibulitis'}], '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'}, {'id': 'D014847', 'term': 'Vulvitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575034', 'term': 'emu Oil'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'enrollment volume due to placebo arm of trial', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2011-02-10', 'studyFirstSubmitQcDate': '2011-02-10', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the Global Response Assessment (GRA) for vulvar pain.', 'timeFrame': 'After 1 month of intervention', 'description': 'Those "moderately" or "markedly" improved on the GRA are responders'}], 'secondaryOutcomes': [{'measure': 'The change in vulvar pain levels', 'timeFrame': 'After 1 month of intervention', 'description': 'Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vulvar pain', 'Vulvodynia', 'Vestibulodynia', 'Vulvar vestibulitis'], 'conditions': ['Vulvodynia', 'Vestibulodynia']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine if vulvar (external female genitalia) pain is decreased with emu oil over a similar placebo oil (no active ingredient) by using measurement devices, examinations, and questionnaires. Topical emu oil has not been scientifically studied for this condition yet, but related reports show no significant side effects or potential benefits.\n\nA total of 30 women will participate in the study at William Beaumont Hospital, Royal Oak.', 'detailedDescription': '* Women of all ages with vulvar pain may participate in this trial.\n* Women will be randomized into 2 groups--a treatment group or placebo group for the 1 month study.\n* At the end of the study, those in the placebo group may choose to participate in a 1 month follow-up evaluation using emu oil.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with vulvar pain upon q-tip exam of \\> 3/10 at 2 or more sites tested.\n* Age 18 or older.\n* Capable of giving informed consent.\n* Capable and willing to follow all study procedures.\n\nExclusion Criteria:\n\n* Pregnant women or those intending to become pregnant during the study period.\n* Vaginitis (may be treated, then tested later).\n* Vulvar disease (other than vulvodynia)-lichen planus, lichen sclerosis, neoplasia, tissue damage due to radiation.\n* The subject is deemed unsuitable for enrollment by the investigators based on their history or physical examination.\n* Neuropathy.\n* Currently in pelvic floor physical therapy.'}, 'identificationModule': {'nctId': 'NCT01295268', 'briefTitle': 'Study of Emu Oil vs. Placebo for Vulvar Pain in Women.', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health East'}, 'officialTitle': 'The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.', 'orgStudyIdInfo': {'id': '2011-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Emu Oil', 'interventionNames': ['Other: Emu Oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'inert oil', 'interventionNames': ['Other: Inert oil']}], 'interventions': [{'name': 'Emu Oil', 'type': 'OTHER', 'description': 'Subjects will apply a specified amount of emu oil daily to area.', 'armGroupLabels': ['Emu Oil']}, {'name': 'Inert oil', 'type': 'OTHER', 'description': 'A specified amount of inert oil will be applied daily to area.', 'armGroupLabels': ['inert oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': "Beaumont Women's Urology Center", 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}], 'overallOfficials': [{'name': 'Donna J Carrico, WHNP, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health East', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}