Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-02-19 @ 6:55 AM
Study NCT ID:
NCT03346759
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2017-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Examining the Impact of Tampon Use on the Vaginal Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jasonbel@med.umich.edu', 'phone': '7342323897', 'title': 'Jason Bell, MD', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for the duration of study participation for each subject (baseline window and menstrual cycles 1, 2, and 3; approximately 14 weeks per subject).', 'eventGroups': [{'id': 'EG000', 'title': 'Tampon A', 'description': 'All participants while using Tampax Pearl Regular Tampons regardless of tampon sequence.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tampon B', 'description': 'All participants while using Playtex Gentle Glide 360 Regular Tampons regardless of tampon sequence.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Tampon of Choice (Third Period)', 'description': 'All participants during the third menstrual cycle.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Relative Abundance of Lactobacillus Species', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tampon A First', 'description': 'Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.'}, {'id': 'OG001', 'title': 'Tampon B First', 'description': 'Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.'}], 'classes': [{'title': 'Baseline to end of first cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.0084', 'groupId': 'OG000', 'lowerLimit': '-.0017', 'upperLimit': '.0274'}, {'value': '-.0014', 'groupId': 'OG001', 'lowerLimit': '-.0148', 'upperLimit': '.0242'}]}]}, {'title': 'Baseline to end of second cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-.00004', 'groupId': 'OG000', 'lowerLimit': '-.0121', 'upperLimit': '.0368'}, {'value': '.0104', 'groupId': 'OG001', 'lowerLimit': '-.0346', 'upperLimit': '.0354'}]}]}, {'title': 'Baseline to end of third menstrual cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-.0350', 'groupId': 'OG000', 'lowerLimit': '-.1723', 'upperLimit': '.0304'}, {'value': '.0238', 'groupId': 'OG001', 'lowerLimit': '.0107', 'upperLimit': '.0349'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)', 'description': 'The differences in relative abundance of Lactobacillus species between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. The Lactobacillus species included here are L. crispatus, L. iners, L. gasseri, and L. jensenii. Thus, a relative abundance of Lactobacillus species equal to 0.9 would mean that 90% of the bacteria identified in a sample are Lactobacillus species.', 'unitOfMeasure': 'relative abundance', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed are those that provided samples through the end of the given menstrual cycle.'}, {'type': 'SECONDARY', 'title': 'Change in Relative Abundance of Gardnerella Vaginalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tampon A First', 'description': 'Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.'}, {'id': 'OG001', 'title': 'Tampon B First', 'description': 'Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.'}], 'classes': [{'title': 'Baseline to end of first cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '.000046', 'groupId': 'OG000', 'lowerLimit': '-.000303', 'upperLimit': '.004230'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-.000124', 'upperLimit': '0'}]}]}, {'title': 'Baseline to end of second cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-.000045', 'groupId': 'OG000', 'lowerLimit': '-.000788', 'upperLimit': '.001620'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-.000115', 'upperLimit': '0'}]}]}, {'title': 'Baseline to 14 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-.000045', 'groupId': 'OG000', 'lowerLimit': '-.004297', 'upperLimit': '.000030'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-.000124', 'upperLimit': '.000075'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)', 'description': 'The differences in relative abundance of Gardnerella vaginalis between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. Thus, a relative abundance of Gardnerella vaginalis equal to 0.9 would mean that 90% of the bacteria identified in a sample are Gardnerella vaginalis.', 'unitOfMeasure': 'relative abundance', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed are those that provided samples through the end of the given menstrual cycle.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tampon A First', 'description': 'Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.'}, {'id': 'FG001', 'title': 'Tampon B First', 'description': 'Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.'}], 'periods': [{'title': 'Enrollment to Baseline Data Collected', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants assigned to the Tampon A First arm who provided at least one vaginal microbiota sample.', 'groupId': 'FG000', 'numSubjects': '13'}, {'comment': 'Participants assigned to the Tampon B First arm who provided at least one vaginal microbiota sample.', 'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'First Menstrual Cycle', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Menstrual Cycle', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Third Menstrual Cycle', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tampon A First', 'description': 'Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.'}, {'id': 'BG001', 'title': 'Tampon B First', 'description': 'Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'spread': '5.0', 'groupId': 'BG000'}, {'value': '24.3', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '26.1', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Non-Hispanic white', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Relative abundance of Lactobacillus species', 'classes': [{'categories': [{'measurements': [{'value': '.9667', 'groupId': 'BG000', 'lowerLimit': '.9192', 'upperLimit': '.9898'}, {'value': '.9727', 'groupId': 'BG001', 'lowerLimit': '.9521', 'upperLimit': '.9877'}, {'value': '.9705', 'groupId': 'BG002', 'lowerLimit': '.9301', 'upperLimit': '.9894'}]}]}], 'paramType': 'MEDIAN', 'description': 'Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. The Lactobacillus species included here are L. crispatus, L. iners, L. gasseri, and L. jensenii. Thus, a relative abundance of Lactobacillus species equal to 0.9 would mean that 90% of the bacteria identified in a sample are Lactobacillus species.', 'unitOfMeasure': 'relative abundance', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Relative abundance of Gardnerella vaginalis', 'classes': [{'categories': [{'measurements': [{'value': '.000091', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '.000094'}, {'value': '.000019', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '.000136'}, {'value': '.000045', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '.000499'}]}]}], 'paramType': 'MEDIAN', 'description': 'Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. Thus, a relative abundance of Gardnerella vaginalis equal to 0.9 would mean that 90% of the bacteria identified in a sample are Gardnerella vaginalis.', 'unitOfMeasure': 'relative abundance', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Participants who provided at least one vaginal microbiota sample.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-29', 'size': 867675, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-08T14:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for one of the first two menstrual cycles during the study. Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the other of the first two menstrual cycle during the study. Subjects used tampons A and B in a randomly assigned order. Subjects then used tampons of their choosing for the third menstrual cycle of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2017-11-15', 'resultsFirstSubmitDate': '2018-05-01', 'studyFirstSubmitQcDate': '2017-11-15', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-25', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Relative Abundance of Lactobacillus Species', 'timeFrame': 'Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)', 'description': 'The differences in relative abundance of Lactobacillus species between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. The Lactobacillus species included here are L. crispatus, L. iners, L. gasseri, and L. jensenii. Thus, a relative abundance of Lactobacillus species equal to 0.9 would mean that 90% of the bacteria identified in a sample are Lactobacillus species.'}], 'secondaryOutcomes': [{'measure': 'Change in Relative Abundance of Gardnerella Vaginalis', 'timeFrame': 'Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)', 'description': 'The differences in relative abundance of Gardnerella vaginalis between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. Thus, a relative abundance of Gardnerella vaginalis equal to 0.9 would mean that 90% of the bacteria identified in a sample are Gardnerella vaginalis.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['tampon', 'menstruation', 'menstrual period'], 'conditions': ['Vaginal Microbiota']}, 'descriptionModule': {'briefSummary': "The vaginal microbiota is the community of bacteria in the vagina. The composition of the vaginal microbiota (which bacteria are present and how many of each are present) is known to affect vaginal health and contribute to the development of bacterial vaginosis (the largest cause of vaginal discharge and malodor, and the most common vaginal disorder). It is also known that the composition of the vaginal microbiota changes across a menstrual cycle with the largest changes happening during a woman's period. However, it is not know how tampon use affects vaginal microbiota composition. This study is being done to learn what effect tampon use has on vaginal microbiota composition during a woman's period and between periods."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* regular menstrual cycles lasting 21-35 days\n* menses lasting for at least 4 days\n* current tampon user\n* good self-reported general health\n* good self-reported vaginal health\n\nExclusion Criteria:\n\n* currently pregnant\n* planning to become pregnant in 4 months following enrollment\n* difficulty using tampons\n* current toxic shock syndrome\n* history of toxic shock syndrome\n* current sexually transmitted infection\n* current urinary tract infection\n* currently using antibiotics\n* antibiotic use in 4 weeks prior to enrollment\n* current antifungal use\n* antifungal use in 4 weeks prior to enrollment\n* autoimmune condition'}, 'identificationModule': {'nctId': 'NCT03346759', 'briefTitle': 'Examining the Impact of Tampon Use on the Vaginal Microbiota', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Examining the Impact of Tampon Use on the Vaginal Microbiota', 'orgStudyIdInfo': {'id': 'HUM00122922'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tampon A First', 'description': 'Subjects were provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.', 'interventionNames': ['Device: Tampon A', 'Device: Tampon B']}, {'type': 'EXPERIMENTAL', 'label': 'Tampon B First', 'description': 'Subjects were provided with 24 Playtex Gentle Glide 360 Regular Tampons (tampon B) to use exclusively for the first of two consecutive menstrual cycles. Subjects were then provided with 24 Tampax Pearl Regular Tampons (tampon A) to use exclusively for the second of two consecutive menstrual cycles. For the third menstrual cycle, subject used tampons of their choosing.', 'interventionNames': ['Device: Tampon A', 'Device: Tampon B']}], 'interventions': [{'name': 'Tampon A', 'type': 'DEVICE', 'description': '24 Tampax Pearl Regular Tampons for use during a single menstrual period.', 'armGroupLabels': ['Tampon A First', 'Tampon B First']}, {'name': 'Tampon B', 'type': 'DEVICE', 'description': '24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.', 'armGroupLabels': ['Tampon A First', 'Tampon B First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Jason Bell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jason Bell, MD, MPH, MS', 'investigatorAffiliation': 'University of Michigan'}}}}