Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05091658
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2021-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Period Tracker Lay User Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lay user ability to read a high and a low result', 'timeFrame': '1 hour', 'description': 'Ability of the lay user to score a positive result above a baseline result using the product scoring scale'}], 'primaryOutcomes': [{'measure': 'Lay user usage', 'timeFrame': '1 hour', 'description': 'Ability of the lay user to perform a test and record their result'}], 'secondaryOutcomes': [{'measure': 'Comprehension of instructions for use', 'timeFrame': '1 hour', 'description': 'Ability of the lay user to understand the information provided in the instructions for use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menstrual Cycles']}, 'descriptionModule': {'briefSummary': 'This study will assess the ability of the lay user to obtain and record a result. Comprehension of the instructions for use of the product will also be assessed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women between the ages of 18 to 45 represent the intended user of the product', 'genderDescription': 'Females are representative of the intended user of the product', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Aged 18 to 45 years\n* Willing to give informed consent and comply with the investigational procedures\n\nExclusion Criteria:\n\n* Used Clearblue® me Period Tracker app Persona or FAM within the last six months\n* Currently or previously employed by SPD, Abbott, Alere, Unipath, P\\&G or affiliates\n* Has an immediate\\* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P\\&G, or affiliates\n* Is a qualified or trainee healthcare professional (HCP)\n* Has professional experience of using dipstick type tests or lateral flow devices\n* Currently breastfeeding, pregnant or seeking to conceive\n* Currently menstruating∆ \\*Immediate relatives are defined as parents, children, siblings or partner/spouse ∆Volunteer can start the study when their period has ended.'}, 'identificationModule': {'nctId': 'NCT05091658', 'briefTitle': 'Period Tracker Lay User Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'SPD Development Company Limited'}, 'officialTitle': 'Period Tracker Lay User Study', 'orgStudyIdInfo': {'id': 'PROTOCOL-1337'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LH Urine Test', 'type': 'DEVICE', 'description': 'Test for qualitative detection of LH in urine'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'MK44 3UP', 'city': 'Bedford', 'state': 'Bedfordshire', 'country': 'United Kingdom', 'facility': 'SPD Development Company Ltd', 'geoPoint': {'lat': 52.13459, 'lon': -0.46632}}], 'overallOfficials': [{'name': 'Sharon Bond', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SPD Development Company'}, {'name': 'Raniero Zazzeroni', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SPD Development Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SPD Development Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}