Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 7:50 AM
Study NCT ID:
NCT00778934
Status:
COMPLETED
Last Update Posted:
2011-10-06
First Post:
2008-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In-Home Use Study to Evaluate Use of an Intimate Health Product in Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-04', 'studyFirstSubmitDate': '2008-10-23', 'studyFirstSubmitQcDate': '2008-10-23', 'lastUpdatePostDateStruct': {'date': '2011-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the effect of product on sexual enhancement by comparing baseline questionnaire responses to the end of study questionnaire responses', 'timeFrame': 'End of study (3 weeks after baseline visit)'}], 'secondaryOutcomes': [{'measure': 'Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.', 'timeFrame': 'throughout duration of the study (+ 30 days for spontaneously reported SAEs)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of an intimate health product on sexual experience in females.', 'detailedDescription': 'Study to evaluate consumer perceptions of a cosmetic intimate health product on sexual experience in females, using a validated psychometric questionnaire.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal, healthy females \\>18 years of age\n* In committed heterosexual relationship for \\>6months\n* Of adequate sexual functioning\n* On acceptable method of birth control\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Allergy to product ingredients\n* Irritation or infection in genital area\n* Unstable or uncontrolled medical condition'}, 'identificationModule': {'nctId': 'NCT00778934', 'briefTitle': 'In-Home Use Study to Evaluate Use of an Intimate Health Product in Females', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': 'A Single-blind, Multi-center, In-home Use Study to Evaluate Sexual Enhancement Effects of Product PD-F-5394 in Females', 'orgStudyIdInfo': {'id': 'CA-P-5739-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Intimate Health Gel', 'interventionNames': ['Other: Intimate Health Gel']}], 'interventions': [{'name': 'Intimate Health Gel', 'type': 'OTHER', 'otherNames': ['Not marketed yet'], 'description': 'Intimate Health Gel', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Center of Marital and Sexual Health of South Florida', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Center for Marital and Sexual Health, Inc.', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}], 'overallOfficials': [{'name': 'Rita Wanser', 'role': 'STUDY_DIRECTOR', 'affiliation': 'J&J CPPW'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Consumer and Personal Products Worldwide', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}