Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-17 @ 10:10 AM
Study NCT ID:
NCT02320227
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2014-12-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'Experimental: Healthy Subjects', 'description': 'Novel Personal Lubricant Miami w/o Fragrance', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Observed Local Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Miami w/o Frag Personal Lubricant', 'description': 'Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 Days', 'description': 'Number of participants with observed local erythema by OB/GYN examination.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Observed Local Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Miami w/o Frag Personal Lubricant', 'description': 'Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': 'Number of participants with observed edema by OB/GYN examination.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Healthy Subjects', 'description': 'Novel Personal Lubricant Miami w/o Fragrance'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Healthy Subjects', 'description': 'Novel Personal Lubricant Miami w/o Fragrance'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 22-59', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', '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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2014-12-09', 'resultsFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-05', 'studyFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Observed Local Erythema', 'timeFrame': '14 Days', 'description': 'Number of participants with observed local erythema by OB/GYN examination.'}, {'measure': 'Number of Participants With Observed Local Edema', 'timeFrame': '14 days', 'description': 'Number of participants with observed edema by OB/GYN examination.'}]}, 'conditionsModule': {'conditions': ['Erythema', 'Edema']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety of a personal lubricant when used as indicated as a personal lubricant in the vagina and vulvar/perineal areas at least four times weekly for two weeks in a population of healthy females'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is female between the ages of 18 and 49 years (at lease 21 subjects) or 50-60 years (no more than 9 subjects);\n* Subject is using adequate non-barrier method of birth control \\[established us of hormonal methods of contraception (oral, injected, implanted, or patch), intrauterine device (IUD) or intrauterine system (IUS), surgical sterilization (e.g. in a monogamous relationship with male partner with vasectomy\\];\n* Subject is free of any vaginal disorders;\n* Subject is 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 (at least 50% and up to 100% of the study population) or is not sexually active (no more than 50% of the population);\n* Subject is a personal lubricant user and agrees to replace her usual personal lubricant with the investigational product;\n* Subject has normal menstrual cycle and is not expected to menstruate 2-4 days before or after the examination days;\n* Subject agrees to use the provided investigational product at least four times weekly (including at least twice weekly during sexual intercourse for subjects with monogamous, male partners) over the two-week study period;\n* Subject 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 examination;\n* Subject is willing to refrain from introducing any new vaginal products, or using vaginal medication or local contraceptives (including condoms and hormonal rings), during the course of this study;\n* Subject agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area for the duration of the study (Note: subjects may continue to use their usual pantyliner, if any);\n* Subject is willing to use a urine pregnancy test provided to them at baseline and on the third visit (Week 2, day 14);\n* Subject has a standard Clinical Research Laboratories, Inc. (CRL) Medical History form on file at CRL and has completed study specific Medical History and Screener/Inclusion forms;\n* Subject has signed and, if sexually active and in a monogamous relationship, whose partner has signed, an Informed Consent Form (ICF) in compliance with 21 CFR Part 50: "Protection of Human Subjects";\n* Subject (and male partner, if applicable) has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;\n* Subject is dependable and able to follow directions as outlined in the protocol;\n* Subject 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* Subject is pregnant, nursing, or planning a pregnancy;\n* Subject is post-menopausal or has had a hysterectomy;\n* Subject is currently using, or has used within two weeks prior to study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories, or antihistamines;\n* Subject has known allergies to vaginal or any cosmetic products (including lotions, moisturizer, powder, sprays, etc.);\n* Subject reports a history of recurrent bladder, vaginal infection, or incontinence;\n* Subject exhibits or reports gynecological abnormalities or has had vaginitis within 60 days prior to study initiation.\n* Subject is expected to menstruate 2-4 days before or after the time of the first, second, and third examination;\n* Subject uses a vaginal ring, diaphragm or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception;\n* Subject has participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation;\n* Subject receives a score higher than 0.5 for erythema, edema, or \\>0 for burning, stinging, or itching, during the first examination or shows any other sign of mucosal irregularities (dryness, papules, vesticulation, fissure).'}, 'identificationModule': {'nctId': 'NCT02320227', 'briefTitle': 'A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Church & Dwight Company, Inc.'}, 'orgStudyIdInfo': {'id': 'ST-7557'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Miami w/o frag Personal lubricant', 'description': 'Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks', 'interventionNames': ['Device: Miami w/o frag Personal lubricant']}], 'interventions': [{'name': 'Miami w/o frag Personal lubricant', 'type': 'DEVICE', 'armGroupLabels': ['Miami w/o frag Personal lubricant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Research Laboratories', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Church & Dwight Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}