Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT00777556
Status:
COMPLETED
Last Update Posted:
2012-10-18
First Post:
2008-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Emergency Contraception Actual Use Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016912', 'term': 'Levonorgestrel'}], 'ancestors': [{'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ustevatrials@tevapharm.com', 'phone': '215-591-3000', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to week 8. Unresolved AEs and pregnancies were followed until resolved.', 'description': 'Includes participants who took study drug. AE information was solicited during scheduled contacts on weeks 1, 4 and 8.', 'eventGroups': [{'id': 'EG000', 'title': 'DR-104', 'description': 'One tablet for emergency contraception', 'otherNumAtRisk': 299, 'otherNumAffected': 0, 'seriousNumAtRisk': 299, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DR-104', 'description': 'One tablet for emergency contraception'}], 'classes': [{'categories': [{'measurements': [{'value': '90.1', 'comment': 'Not part of analysis plan', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '86.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DR-104', 'description': 'One tablet for emergency contraception'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'comment': 'not part of analysis plan', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '84.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1', 'description': "The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions.", 'unitOfMeasure': 'percentage of treated participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible participants who appropriately self-selected and used the product.'}, {'type': 'SECONDARY', 'title': 'Participants With Treatment-Emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DR-104', 'description': 'One tablet for emergency contraception'}], 'classes': [{'title': 'At least one TEAE', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Withdrawn from study due to an AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'At least one SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to week 8', 'description': 'Treatment-emergent adverse events included adverse events reported during the protocol-specified following up contacts at weeks 1, 4 and 8 or at any other participant contact for participants who took study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population of participants who took study drug'}, {'type': 'SECONDARY', 'title': 'Participants Summarized by Repeat Use of Emergency Contraception (EC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'DR-104', 'description': 'One tablet for emergency contraception'}], 'classes': [{'title': 'Repeat uses: 0', 'categories': [{'measurements': [{'value': '251', 'groupId': 'OG000'}]}]}, {'title': 'Repeat uses: 1', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Repeat uses: 2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Repeat uses: 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to week 8', 'description': 'As each participant dispensed Plan B® 1.5 was only given one tablet, repeat use of emergency contraception (EC) indicates use of an EC product other than the study product. Categories reflect the number of repeat uses.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants dispensed the product'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DR-104', 'description': 'One tablet for emergency contraception'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrolled; signed informed consent', 'groupId': 'FG000', 'numSubjects': '343'}]}, {'type': 'Dispensed Product', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}]}, {'type': 'Safety Population', 'achievements': [{'comment': 'Participants who used the product; two were given product in error (inappropriately self-selected)', 'groupId': 'FG000', 'numSubjects': '299'}]}, {'type': 'Used Product', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed all 3 follow-up visits', 'groupId': 'FG000', 'numSubjects': '277'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}], 'dropWithdraws': [{'type': 'Inappropriate self-selection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'Dispensed but did not use product', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Did not complete all 3 follow-up visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}], 'preAssignmentDetails': 'Three hundred and seventy-nine candidates were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'DR-104', 'description': 'One tablet for emergency contraception'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '343', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': '11-13 years old', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '14 years old', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': '15 years old', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}, {'title': '16 years old', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}]}]}, {'title': '17 years old', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '343', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Latina', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}, {'title': 'Asian/Pacific Islander', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}]}]}, {'title': 'Native American/Alaskan Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnic Latina/Hispanic', 'classes': [{'title': 'No answer', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '151', 'groupId': 'BG000'}]}]}, {'title': "Don't know", 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Do you describe yourself as ethnic Latina/Hispanic?', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 343}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-14', 'studyFirstSubmitDate': '2008-10-21', 'resultsFirstSubmitDate': '2012-09-14', 'studyFirstSubmitQcDate': '2008-10-21', 'lastUpdatePostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-14', 'studyFirstPostDateStruct': {'date': '2008-10-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions', 'timeFrame': 'Day 1', 'description': "The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them."}, {'measure': 'Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions', 'timeFrame': 'Week 1', 'description': "The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions."}], 'secondaryOutcomes': [{'measure': 'Participants With Treatment-Emergent Adverse Events (TEAE)', 'timeFrame': 'Day 1 to week 8', 'description': 'Treatment-emergent adverse events included adverse events reported during the protocol-specified following up contacts at weeks 1, 4 and 8 or at any other participant contact for participants who took study drug.'}, {'measure': 'Participants Summarized by Repeat Use of Emergency Contraception (EC)', 'timeFrame': 'up to week 8', 'description': 'As each participant dispensed Plan B® 1.5 was only given one tablet, repeat use of emergency contraception (EC) indicates use of an EC product other than the study product. Categories reflect the number of repeat uses.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Emergency Contraception']}, 'descriptionModule': {'briefSummary': 'This is a non-comparative case series study to assess the ability of females 11-16 years of age, inclusive, who are requesting emergency contraception (EC) to use the study product, DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.', 'detailedDescription': 'To simulate an over-the-counter (OTC) setting, each potential subject was expected to read the label text on the outside of the study package and determine whether and how to use the study product without provider direction or assistance. The study product, Plan B® 1.5, was to be dispensed only to those subjects who appropriately self-selected and indicated that they wanted to participate in the study and receive study product. Subjects could also appropriately self-select not to use the study product.\n\nFollow-up contact was to be conducted at approximately one, four, and eight weeks following the date the subject was dispensed study product. At these contacts, subjects answered questions regarding product use, health problems since last contact, and pregnancy status. Subjects were not to be permitted to enroll more than once in this Actual Use Study, however to assess repeat use of emergency contraceptives (EC) (use in addition to the study product) subjects were also queried at the one-, four-, and eight-week follow-up contacts regarding use of additional EC.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and 11-16 years of age, inclusive\n* Subject must be requesting emergency contraception for her own use (not for use by another person) and for current (not future) use\n* Subject can read and understand English, according to her own judgment\n* Others as dictated by FDA-approved protocol'}, 'identificationModule': {'nctId': 'NCT00777556', 'briefTitle': 'Emergency Contraception Actual Use Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents', 'orgStudyIdInfo': {'id': 'DR-LEV-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DR-104', 'description': 'One tablet for emergency contraception', 'interventionNames': ['Drug: DR-104']}], 'interventions': [{'name': 'DR-104', 'type': 'DRUG', 'otherNames': ['Plan B® 1.5', 'Plan B One-Step®', 'levonorgestrel'], 'description': 'One 1.5 mg tablet of levonorgestrel for emergency contraception within 72 hours following unprotected sexual intercourse.', 'armGroupLabels': ['DR-104']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Research Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Duramed Research Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Duramed Research Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duramed Research Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Duramed Research Protocol Chair', 'role': 'STUDY_CHAIR', 'affiliation': 'Duramed Research, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duramed Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}