Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-11 @ 9:11 PM
Study NCT ID:
NCT01746732
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2012-12-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Evacetrapib in Healthy Female Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'C568301', 'term': 'evacetrapib'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ortho-Cyclen (Lead-in Phase)', 'description': 'Ortho-Cyclen oral doses of (35 mcg ethinyl estradiol and 250 mcg norgestimate) once daily for 28 days (Days 1 to 28)', 'otherNumAtRisk': 22, 'otherNumAffected': 9, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily for 28 days (lead-in period). Then, Ortho-Cyclen orally for 28 Days (Days 1 to 28) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration', 'otherNumAtRisk': 17, 'otherNumAffected': 5, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen administered orally for 28 days (lead-in period). Then, Ortho-Cyclen orally for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally for 21 days (Days 1 to 21) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration\n\nEvacetrapib: Oral administration', 'otherNumAtRisk': 21, 'otherNumAffected': 5, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Procedural dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration'}, {'id': 'OG001', 'title': 'Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)'}], 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'spread': '35', 'groupId': 'OG000'}, {'value': '70.6', 'spread': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose', 'unitOfMeasure': 'picogram per milliliter (pg/ml)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration'}, {'id': 'OG001', 'title': 'Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration Evacetrapib: Oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '907', 'spread': '31', 'groupId': 'OG000'}, {'value': '840', 'spread': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose', 'unitOfMeasure': 'picogram x hour per ml (pg*hour/ml)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration'}, {'id': 'OG001', 'title': 'Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration Evacetrapib: Oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'spread': '65', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '66', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration'}, {'id': 'OG001', 'title': 'Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration Evacetrapib: Oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '12.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '5.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Maximum Concentration (Cmax) of Norelgestromin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration'}, {'id': 'OG001', 'title': 'Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)'}], 'classes': [{'categories': [{'measurements': [{'value': '1410', 'spread': '21', 'groupId': 'OG000'}, {'value': '1830', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration'}, {'id': 'OG001', 'title': 'Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)'}], 'classes': [{'categories': [{'measurements': [{'value': '16200', 'spread': '21', 'groupId': 'OG000'}, {'value': '18100', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose', 'unitOfMeasure': 'pg*hour/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration'}, {'id': 'OG001', 'title': 'Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)'}], 'classes': [{'categories': [{'measurements': [{'value': '397', 'spread': '35', 'groupId': 'OG000'}, {'value': '422', 'spread': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods.\n\nOrtho-Cyclen: Oral administration'}, {'id': 'OG001', 'title': 'Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen administered orally, once daily (QD) for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, once daily (QD) for 21 days (Days 1 to 21)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.53', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '12.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '1.02', 'upperLimit': '5.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (OC) of (35 microgram \\[mcg\\] ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD) for 28 days (Days 1 to 28)'}, {'id': 'FG001', 'title': 'Ortho-Cyclen Then Ortho-Cyclen + Evacetrapib; Sequence AB', 'description': 'Treatment A OC administered orally, QD for 28 days (Days 1 to 28)\n\nTreatment B OC administered orally, QD for 28 days (Days 1 to 28) and 130 milligram (mg) Evacetrapib orally, QD for 21 days (Days 1 to 21)'}, {'id': 'FG002', 'title': 'Ortho-Cyclen + Evacetrapib Then Ortho-Cyclen; Sequence BA', 'description': 'Treatment B OC administered orally, QD for 28 days (Days 1 to 28) and 130 mg Evacetrapib orally, QD for 21 days (Days 1 to 21)\n\nTreatment A OC administered orally, QD for 28 days (Days 1 to 28)'}], 'periods': [{'title': 'Lead-In Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Participants Received at Least 1 Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ortho-Cyclen and Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, QD for 28 days (lead-in period).\n\nTreatment A Ortho-Cyclen administered orally, QD for 28 Days (Days 1 to 28) Treatment B Ortho-Cyclen orally, QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD for 21 days (Days 1 to 21)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'spread': '6.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Females', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Twenty-two subjects received at least one dose of study drug and are included in the summary of subject demographics'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-18', 'studyFirstSubmitDate': '2012-12-07', 'resultsFirstSubmitDate': '2018-02-18', 'studyFirstSubmitQcDate': '2012-12-07', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-18', 'studyFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose'}, {'measure': 'PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose'}, {'measure': 'PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose'}, {'measure': 'PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose'}, {'measure': 'PK: Maximum Concentration (Cmax) of Norelgestromin', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose'}, {'measure': 'PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose'}, {'measure': 'PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose'}, {'measure': 'PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin', 'timeFrame': 'Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones found in the blood will be measured and compared when taken alone and when taken with evaceptrapib. Each woman will participate in two study periods. Information about any side effects that may occur will also be collected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are pre-menopausal females, and who are healthy as determined by medical history and physical examination\n* Have a body mass index of 18 to 30 kilograms per square meter (kg/m\\^2)\n\nExclusion Criteria:\n\n* Have known allergies to evacetrapib and Ortho-Cyclen (ethinyl estradiol and norgestimate), related compounds or any components of the formulation\n* Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study\n* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening\n* Have taken injectable contraceptives within 12 months prior to the first dose of the lead-in period or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of the lead-in period\n* Use of any tobacco- or nicotine-containing products within 6 months prior to the lead-in phase and during the study'}, 'identificationModule': {'nctId': 'NCT01746732', 'briefTitle': 'A Study of Evacetrapib in Healthy Female Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Effects of Evacetrapib (LY2484595) on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects', 'orgStudyIdInfo': {'id': '14617'}, 'secondaryIdInfos': [{'id': 'I1V-MC-EIAP', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ortho-Cyclen', 'description': 'Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods. Treatment A', 'interventionNames': ['Drug: Ortho-Cyclen']}, {'type': 'EXPERIMENTAL', 'label': 'Ortho-Cyclen + Evacetrapib', 'description': 'Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods. Treatment B', 'interventionNames': ['Drug: Ortho-Cyclen', 'Drug: Evacetrapib']}], 'interventions': [{'name': 'Ortho-Cyclen', 'type': 'DRUG', 'description': 'Oral administration', 'armGroupLabels': ['Ortho-Cyclen', 'Ortho-Cyclen + Evacetrapib']}, {'name': 'Evacetrapib', 'type': 'DRUG', 'otherNames': ['LY2484595'], 'description': 'Oral administration', 'armGroupLabels': ['Ortho-Cyclen + Evacetrapib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}