Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-04-17 @ 12:24 AM
Study NCT ID:
NCT02737592
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2016-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004890', 'term': 'Erythema'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'annahita.ghassemi@churchdwight.com', 'phone': '6098061200', 'title': 'Annahita Ghassemi', 'organization': 'Church & Dwight Co., Inc'}, 'certainAgreement': {'otherDetails': 'Master service agreement and confidentiality agreement in place', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Healthy Subject', 'description': 'Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks\n\nTrojan "Simply Pleasure" Personal Lubricant: silicone base without sensate', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Observed Local Erythema Based on 5 Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subject', 'description': 'Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks\n\nTrojan "Simply Pleasure" Personal Lubricant: silicone base without sensate'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks', 'description': 'Number of subjects with observed local erythema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subject', 'description': 'Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks\n\nTrojan "Simply Pleasure" Personal Lubricant: silicone base without sensate'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 weeks', 'description': 'Number of subjects with observed local edema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Subject', 'description': 'Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks\n\nTrojan "Simply Pleasure" Personal Lubricant: silicone base without sensate'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Subject', 'description': 'Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks\n\nTrojan "Simply Pleasure" Personal Lubricant: silicone base without sensate'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 20 - 60', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-20', 'studyFirstSubmitDate': '2016-03-22', 'resultsFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-30', 'studyFirstPostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Observed Local Erythema Based on 5 Point Scale', 'timeFrame': '2 weeks', 'description': 'Number of subjects with observed local erythema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema'}, {'measure': 'Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale', 'timeFrame': '2 weeks', 'description': 'Number of subjects with observed local edema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema'}]}, 'conditionsModule': {'conditions': ['Erythema', 'Edema']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety of a personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no participation in a similar study 2-weeks prior\n* may be post-menopausal or have had a hysterectomy\n* if sexually active, and of child bearing potential, subjects is using adequate non-barrier method of birth control\n* free from any vaginal disorders\n* sexually active and in a monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study or is not sexually active\n* personal lubricant user and agrees to replace her usual personal lubricant with the investigational product\n* can start regardless of where they are in their cycles\n* agrees to use the provided investigational product at least four time weekly over the two week study period\n* exhibits no clinically significant evidence of vulvar or vaginal irritation, as determined by a study doctor, and no reports of sensory irritation at the baseline exam\n* willing to refrain from introducing any new vaginal products, or using vaginal medications or local contraceptives during study\n* agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area\n* willing to use a urine pregnancy test provided to them at baseline and on third visit\n* standard medical history form on file\n* signed informed consent\n* completed HIPAA\n* dependable and able to follow directions as outlined\n* receives a score of 0 or 0.5 for erythema and edema; and 0 for sensorial irritation (burning, stinging, itching and dryness) during the first examination.\n\nExclusion Criteria:\n\n* pregnant, nursing or planning a pregnancy\n* currently using or has used within two weeks prior to the study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories or antihistamines\n* known allergies to vaginal or any cosmetic products\n* reports history of recurrent bladder, vaginal infections or incontinence\n* exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation\n* uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception\n* participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation\n* receives a score higher than 0/5 for erythema, edema or \\>0 for burning, stinging, or itching, during first examination or shows any other sign of mucosal irregularities'}, 'identificationModule': {'nctId': 'NCT02737592', 'briefTitle': 'A Clinical Study to Evaluate the Safety of a Personal Lubricant in Healthy Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Church & Dwight Company, Inc.'}, 'orgStudyIdInfo': {'id': 'ST-7610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy subject', 'description': 'Healthy subject exposed to Trojan "Simply Pleasures" Personal Lubricant at least four times weekly for two weeks', 'interventionNames': ['Device: Trojan "Simply Pleasure" Personal Lubricant']}], 'interventions': [{'name': 'Trojan "Simply Pleasure" Personal Lubricant', 'type': 'DEVICE', 'description': 'silicone base without sensate', 'armGroupLabels': ['Healthy subject']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Research Laboratories, LLC', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Church & Dwight Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}