Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-29 @ 8:53 PM
Study NCT ID:
NCT01236768
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2010-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019304', 'term': 'Ethinyl Estradiol-Norgestrel Combination'}, {'id': 'D003278', 'term': 'Contraceptives, Oral, Hormonal'}], 'ancestors': [{'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D003276', 'term': 'Contraceptives, Oral'}, {'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000080066', 'term': 'Contraceptive Agents, Hormonal'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lflood@agiletherapeutics.com', 'phone': '609-683-1880', 'title': 'Lisa Flood, Associate Director of Clinical Operations', 'organization': 'Agile Therapeutics'}, 'certainAgreement': {'otherDetails': 'Review and approval by Agile Therapeutics, Inc. of any publication, including oral presentations and abstracts, utilizing data or any information from the ATI-CL13 study is required prior to publication submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'AG200-15', 'description': 'Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)\n\nAG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.', 'otherNumAtRisk': 177, 'deathsNumAtRisk': 177, 'otherNumAffected': 42, 'seriousNumAtRisk': 177, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Levora', 'description': 'oral contraceptive containing 150mcg of LNG and 30mcg of EE\n\nLevora: One tablet of Levora will be taken each day for a 28 day cycle.', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 45, 'seriousNumAtRisk': 188, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Murine Typhus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pregnancy Reported as Pearl Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG200-15', 'description': 'Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)\n\nAG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.'}, {'id': 'OG001', 'title': 'Levora', 'description': 'hormonal oral contraceptive'}], 'classes': [{'categories': [{'measurements': [{'value': '8.19', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '16.19'}, {'value': '6.80', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '13.44'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.', 'unitOfMeasure': 'Pearl Index', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population ages 18-35.'}, {'type': 'SECONDARY', 'title': 'Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG200-15', 'description': 'Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)\n\nAG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.'}, {'id': 'OG001', 'title': 'Levora', 'description': 'oral contraceptive containing 150mcg of LNG and 30mcg of EE\n\nLevora: One tablet of Levora will be taken each day for a 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Adverse events', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Any subject who applied a patch.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cycle Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG200-15', 'description': 'Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)\n\nAG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.'}, {'id': 'OG001', 'title': 'Levora', 'description': 'oral contraceptive containing 150mcg of LNG and 30mcg of EE\n\nLevora: One tablet of Levora will be taken each day for a 28 day cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.089', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparative evaluation of AG200-15 and Levora', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Comparative analysis of AG200-15 and Levora for breakthrough bleeding and/or spotting.'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles.', 'unitOfMeasure': 'percent cycles with BTB or BTS', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with relevant breakthrough bleeding (BTB) and/or spotting (BTS), and drug information for a cycle.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Irritation and Itching at Application Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AG200-15', 'description': 'Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)\n\nAG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.'}], 'classes': [{'title': 'Irritation Score (cycles 1-6 combined)', 'categories': [{'measurements': [{'value': '1.15', 'spread': '0.914', 'groupId': 'OG000'}]}]}, {'title': 'Itching Score (cycles 1-6 combined)', 'categories': [{'measurements': [{'value': '1.31', 'spread': '0.851', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'AG200-15 irritation and itching scores are defined as follows:\n\n0=none\n\n1. mild\n2. moderate\n3. severe', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject self-reported worse irritation score in a cycle.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AG200-15', 'description': 'Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)\n\nAG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.'}, {'id': 'OG001', 'title': 'Levora', 'description': 'oral contraceptive containing 150mcg of LNG and 30mcg of EE\n\nLevora: One tablet of Levora will be taken each day for a 28 day cycle.'}], 'classes': [{'title': 'LNG cycle 3', 'categories': [{'measurements': [{'value': '2244', 'groupId': 'OG000', 'lowerLimit': '1887', 'upperLimit': '2600'}, {'value': '3474', 'groupId': 'OG001', 'lowerLimit': '3044', 'upperLimit': '3904'}]}]}, {'title': 'LNG cycle 6', 'categories': [{'measurements': [{'value': '1743', 'groupId': 'OG000', 'lowerLimit': '1478', 'upperLimit': '2007'}, {'value': '3682', 'groupId': 'OG001', 'lowerLimit': '3136', 'upperLimit': '4228'}]}]}, {'title': 'EE cycle 3', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '38.7', 'upperLimit': '50.3'}, {'value': '50.6', 'groupId': 'OG001', 'lowerLimit': '43.0', 'upperLimit': '58.3'}]}]}, {'title': 'EE cycle 6', 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000', 'lowerLimit': '30.1', 'upperLimit': '39.4'}, {'value': '54.7', 'groupId': 'OG001', 'lowerLimit': '44.8', 'upperLimit': '64.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months and 6 months', 'description': 'Measurement of plasma levels of levonorgestrel and ethinyl estradiol.', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects with available LNG data for cycle 3 or cycle 6'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adhesion at Application Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AG200-15', 'description': 'Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)\n\nAG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '1.118', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Measurement of adhesion of application site is defined as follows:\n\n0: \\>=90% adhered (no lifting)\n\n1. \\>=75% adhered but \\<90% (some edges showing lifting)\n2. \\>=50% adhered but \\<75% (half of the patch lifts off)\n3. \\<50% (\\> half of patch lifts off, but not detached)\n4. patch completely detached', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects that have documented adhesion scores.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AG200-15', 'description': 'Transdermal contraceptive delivery system (TCDS)'}, {'id': 'FG001', 'title': 'Levora', 'description': 'hormonal oral contraceptive'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '206'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '61'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AG200-15', 'description': 'Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)\n\nAG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.'}, {'id': 'BG001', 'title': 'Levora', 'description': 'hormonal oral contraceptive'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population (number of subjects that received drug)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'dispFirstSubmitDate': '2012-07-10', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2010-11-05', 'dispFirstSubmitQcDate': '2013-01-28', 'resultsFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2010-11-05', 'dispFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-17', 'studyFirstPostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cycle Control', 'timeFrame': '6 months', 'description': 'The percentage of cycles with breakthrough bleeding or spotting episodes during all cycles. Numerator is total number of cycles with event, denominator is total number of cycles.'}, {'measure': 'Irritation and Itching at Application Site', 'timeFrame': '6 months', 'description': 'AG200-15 irritation and itching scores are defined as follows:\n\n0=none\n\n1. mild\n2. moderate\n3. severe'}, {'measure': 'Pharmacokinetics of Levonorgestrel (LNG) and Ethinyl Estradiol (EE)', 'timeFrame': '3 months and 6 months', 'description': 'Measurement of plasma levels of levonorgestrel and ethinyl estradiol.'}, {'measure': 'Adhesion at Application Site', 'timeFrame': '6 months', 'description': 'Measurement of adhesion of application site is defined as follows:\n\n0: \\>=90% adhered (no lifting)\n\n1. \\>=75% adhered but \\<90% (some edges showing lifting)\n2. \\>=50% adhered but \\<75% (half of the patch lifts off)\n3. \\<50% (\\> half of patch lifts off, but not detached)\n4. patch completely detached'}], 'primaryOutcomes': [{'measure': 'Pregnancy Reported as Pearl Index', 'timeFrame': '6 months', 'description': 'Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '6 months', 'description': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contraceptive'], 'conditions': ['Contraception']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.', 'detailedDescription': 'Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sexually active women requesting contraception\n* Regular menses every 24 - 35 days\n* In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values\n\nExclusion Criteria:\n\n* Known or suspected pregnancy\n* Lactating women\n* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape\n* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)\n* Use of other contraceptive methods than study medication'}, 'identificationModule': {'nctId': 'NCT01236768', 'acronym': 'ATI-CL13', 'briefTitle': 'Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm', 'organization': {'class': 'INDUSTRY', 'fullName': 'Agile Therapeutics'}, 'officialTitle': 'An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System in Comparison to an Oral Contraceptive (OC) Containing 150 mcg LNG and 30 mcg EE', 'orgStudyIdInfo': {'id': 'ATI-CL13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AG200-15', 'description': 'Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)', 'interventionNames': ['Drug: AG200-15']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levora', 'description': 'oral contraceptive containing 150mcg of LNG and 30mcg of EE', 'interventionNames': ['Drug: Levora']}], 'interventions': [{'name': 'AG200-15', 'type': 'DRUG', 'otherNames': ['Transdermal contraceptive delivery system (TCDS)'], 'description': 'Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.', 'armGroupLabels': ['AG200-15']}, {'name': 'Levora', 'type': 'DRUG', 'otherNames': ['Hormonal oral contraceptive'], 'description': 'One tablet of Levora will be taken each day for a 28 day cycle.', 'armGroupLabels': ['Levora']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85614', 'city': 'Green Valley', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 31.85425, 'lon': -110.9937}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91307', 'city': 'West Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '47630', 'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'zip': '40291', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '27284', 'city': 'Kernersville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.11986, 'lon': -80.07365}}, {'zip': '45322', 'city': 'Englewood', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.87756, 'lon': -84.30217}}, {'zip': '74105', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '78414', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '23606', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Marie Foegh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Agile Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Agile Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}