Ignite Creation Date:
2025-12-24 @ 11:59 PM
Ignite Modification Date:
2026-02-22 @ 2:04 AM
Study NCT ID:
NCT01948258
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2013-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.johnson@spdspark.com', 'phone': '01234835486', 'title': 'Dr Sarah Johnson, Head of Clinical and Regulatory Affairs', 'organization': 'SPD Swiss Precision Diagnostics GmbH/SPD Development Company Ltd'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There was some incomplete data with women not using the monitor on all the days that ideally would have been tested. We believe the missing data did not affect the objectives of the study.'}}, 'adverseEventsModule': {'timeFrame': 'Duration of study, one cycle per volunteer.', 'eventGroups': [{'id': 'EG000', 'title': 'Fertility Monitor', 'description': 'Use of Clearblue Fertility Monitor', 'otherNumAtRisk': 393, 'deathsNumAtRisk': 393, 'otherNumAffected': 0, 'seriousNumAtRisk': 393, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fertility Monitor', 'description': 'Use of Clearblue Fertility Monitor'}], 'classes': [{'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one month use', 'description': 'Acceptance criteria is that ≥80% of volunteers will score 3 or less on the Likert scale in a home setting by demonstrating ease of use and comprehension of the instructions for use.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Volunteers whose data contributes to the full analysis set.'}, {'type': 'SECONDARY', 'title': 'Correct Identification of Monitor Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fertility Monitor', 'description': 'Use of Clearblue Fertility Monitor'}], 'classes': [{'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one month', 'description': 'To demonstrate correct user identification of fertility status and test days and to determine the performance of the monitor in consumer hands.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Volunteers who completed the study, who had daily diary entries and monitor download data for days on which a test was conducted'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pregnancy Test Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fertility Monitor', 'description': 'Use of Clearblue Fertility Monitor'}], 'classes': [{'title': 'Monitor test result in agreement with predicate', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '99.9'}]}]}, {'title': 'Monitor test result in agreement with hCG levels', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '98.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one month', 'description': 'Pregnancy test results will also be compared with both the performance of a currently marketed pregnancy test when used by a trained technician and quantitative hCG concentration.', 'unitOfMeasure': 'percentage of tests in agreement', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Volunteers who completed the study, comparison of Clearblue Fertility Monitor pregnancy test results and a marketed pregnancy test. Results for all tests conducted.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fertility Monitor', 'description': 'Use of Clearblue Advanced Fertility Monitor'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'Did not complete by cut-off date', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Withdrawal by SPD', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Health Care Professional', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'Removed from statistical analysis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study was conducted by volunteers remotely and managed by the clinical department at SPD. For the study, 395 females aged between 18-45 years were recruited via internet advertising and from women who had participated in previous SPD studies. The first volunteer was recruited on 1st March 2013, the last was recruited on 1st August 2013.', 'preAssignmentDetails': 'Volunteers were instructed to test for pregnancy prior to starting the study. If pregnant before the start of their cycle they were withdrawn and classified as a pre-study pregnancy. Volunteers were also withdrawn if identified as health care professionals.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fertility Monitor', 'description': 'Use of Clearblue Fertility Monitor'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age of Participants', 'categories': [{'title': '18-25', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': '26-30', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': '31-35', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': '36-40', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': '41-45', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age of Participants who used the new Clearblue Advanced Fertility Monitor', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '233', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'Asian : Bangladeshi', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian : Chinese', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian : Indian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian : Pakistani', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Asian : South Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian : Other Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black: African', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Black: Caribbean', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black: Other Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White: American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White: Australian/New Zealander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White: Eastern European', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White: Mediterranean/Middle Eastern', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White: Western European', 'measurements': [{'value': '210', 'groupId': 'BG000'}]}, {'title': 'White: Other White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Mixed', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest qualification', 'classes': [{'categories': [{'title': 'Post-graduate qualifications', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Degree or equivalent (college degree)', 'measurements': [{'value': '77', 'groupId': 'BG000'}]}, {'title': 'Other higher education below degree level (associa', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'A levels, vocational level 3 and equivalents (age', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'GCSE (Grade A*-C), vocational level 2 and equivale', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Qualifications at level 1 and below', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Other qualifications', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'No qualifications', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Occupation', 'classes': [{'categories': [{'title': 'Managerial', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Professional', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': 'Associate Professional / Technical', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Administrative / Secretarial', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Skilled Trade', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Personal Services', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Sales / Customer Services', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Manufacturing / Driver', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Support Personnel', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Student', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Homemaker', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All volunteers recruited'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 395}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2013-09-18', 'resultsFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-31', 'studyFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pregnancy Test Result', 'timeFrame': 'one month', 'description': 'Pregnancy test results will also be compared with both the performance of a currently marketed pregnancy test when used by a trained technician and quantitative hCG concentration.'}], 'primaryOutcomes': [{'measure': 'The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting', 'timeFrame': 'one month use', 'description': 'Acceptance criteria is that ≥80% of volunteers will score 3 or less on the Likert scale in a home setting by demonstrating ease of use and comprehension of the instructions for use.'}], 'secondaryOutcomes': [{'measure': 'Correct Identification of Monitor Status', 'timeFrame': 'one month', 'description': 'To demonstrate correct user identification of fertility status and test days and to determine the performance of the monitor in consumer hands.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnancy'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'This study will assess the use of the new Clearblue Advanced Fertility Monitor for one menstrual cycle in a home setting by female volunteers seeking to get pregnant.', 'detailedDescription': "The Clearblue Fertility Monitor is a personal monitor designed to be used with disposable test sticks for the semi-quantitative measurement of estrone-3-glucuronide (E3G) and luteinising hormone (LH) in women's urine. This personal information allows women to identify their fertile window and appropriately time intercourse in order to maximise their chances of conception. A new version of this monitor (Clearblue Advanced Fertility Monitor) has been developed with additional functionality including the option to test for pregnancy.\n\nThis study will assess the volunteer ease of use of the new Clearblue Advanced Fertility Monitor and the understanding and interpretation of the results by the user. This is a single centre clinical study which will be conducted by volunteers at their residence and co-ordinated by the clinical department at SPD Development Company Ltd.\n\nA minimum of 100 female volunteers representing the target consumer will be required to use the new Clearblue Advanced Fertility Monitor at home as per the instructions for use. This will involve them setting up the monitor, using the monitor for one full cycle and then setting up the monitor for their next cycle unless they test for pregnancy and get a pregnant result.\n\nAt the end of one full cycle, all volunteers will complete a study questionnaire which includes sections on comprehension of the instructions for use, ease of use and interpretation of test results."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female\n* Aged 18 - 45 years\n* Willing to provide written informed consent to participate in the study and comply to the investigational procedures\n* Naive to similar marketed products including current Clearblue fertility monitor and Persona\n* Two natural cycles immediately prior to entering the study, each lasting between 21 and 42 days\n* Seeking to become pregnant\n\nExclusion Criteria:\n\n* Unwilling to provide written informed consent to participate in the study or comply with study procedures\n* Employees of SPD, Proctor \\& Gamble or Alere\n* Have a condition that is known to be contra-indicated in pregnancy\n* Usually have menstrual cycles which are shorter than 21 days or longer than 42 days\n* Using or have used in their last 2 cycles, hormonal contraceptives including oral, emergency oral, implants, patches, transdermal injections, vaginal ring and progesterone intrauterine systems (IUS)\n* Using or have used in the last 2 cycles, infertility medications or hormone replacement therapy containing hCG or LH\n* Taking clomiphene citrate or other ovulation induction drugs\n* Are using any treatment which may affect the menstrual cycle\n* Have recently been pregnant, miscarried or breastfeeding\n* Have been diagnosed with polycystic ovarian syndrome (PCOS)\n* Are peri- or post-menopausal e.g. experiencing symptoms such as irregular menstrual periods, hot flushes, night sweats, sleep disturbances and mood swings\n* Are taking antibiotics containing tetracyclines\n* Have impaired liver or kidney function\n* Have previously participated in a SPD 'trying to conceive' study"}, 'identificationModule': {'nctId': 'NCT01948258', 'briefTitle': 'Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'SPD Development Company Limited'}, 'officialTitle': 'Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study', 'orgStudyIdInfo': {'id': '0481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clearblue Advanced Fertility Monitor', 'description': 'Use of Clearblue Fertility Monitor', 'interventionNames': ['Device: Clearblue Advanced Fertility Monitor']}], 'interventions': [{'name': 'Clearblue Advanced Fertility Monitor', 'type': 'DEVICE', 'description': 'Clearblue Advanced Fertility Monitor used for one menstrual cycle in a home setting', 'armGroupLabels': ['Clearblue Advanced Fertility Monitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'MK43 7JX', 'city': 'Bedford', 'state': 'Bedfordshire', 'country': 'United Kingdom', 'facility': 'SPD Development Company Ltd', 'geoPoint': {'lat': 52.13459, 'lon': -0.46632}}], 'overallOfficials': [{'name': 'Sarah Johnson, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SPD Swiss Precision Diagnostics GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Overall results will be shared after study completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SPD Development Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}