{"protocolSection":{"identificationModule":{"nctId":"NCT04172987","orgStudyIdInfo":{"id":"17103"},"secondaryIdInfos":[{"id":"I8F-MC-GPGR","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants","officialTitle":"Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects"},"statusModule":{"statusVerifiedDate":"2022-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-02-26","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-02-09","type":"ACTUAL"},"completionDateStruct":{"date":"2021-02-09","type":"ACTUAL"},"studyFirstSubmitDate":"2019-11-20","studyFirstSubmitQcDate":"2019-11-20","studyFirstPostDateStruct":{"date":"2019-11-21","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-06-09","resultsFirstSubmitQcDate":"2022-06-09","resultsFirstPostDateStruct":{"date":"2023-03-27","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-06-09","lastUpdatePostDateStruct":{"date":"2023-03-27","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to look at how the body processes the commonly prescribed birth control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side effects that may occur will also be collected.\n\nScreening is required within 28 days prior to the start of the study. For each participant, the study will last about 20 weeks, including screening."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":40,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)","type":"EXPERIMENTAL","description":"Participants received a 28-day packet of a combination oral contraceptive (OC) containing 21 days of tablets that consist of active ingredients (0.035 mg ethinyl estradiol (EE) and 0.25 mg norgestimate (NGM)) self-administered orally once-daily (QD) on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day.","interventionNames":["Drug: EE/NGM"]},{"label":"EE/NGM + Tirzepatide (Period 2)","type":"EXPERIMENTAL","description":"Participants received a 28-day packet of a combination OC containing 21 days of tablets that consist of active ingredients (0.035 mg EE and 0.25 mg NGM) self-administered orally QD on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day and a single dose 5 mg tirzepatide administered subcutaneously (SC).","interventionNames":["Drug: Tirzepatide","Drug: EE/NGM"]}],"interventions":[{"type":"DRUG","name":"Tirzepatide","description":"Administered SC","armGroupLabels":["EE/NGM + Tirzepatide (Period 2)"],"otherNames":["LY3298176"]},{"type":"DRUG","name":"EE/NGM","description":"Combination oral contraceptive administered orally","armGroupLabels":["EE/NGM + Tirzepatide (Period 2)","Ethinyl Estradiol + Norgestimate (EE/NGM) Alone (Period 1)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Period 1 and Period 2, Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Ethinylestradiol (EE)","description":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\\[0-tau\\]) of Ethinylestradiol (EE)","timeFrame":"Period 1 and Period 2: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose"},{"measure":"Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EE","description":"PK: Cmax of EE","timeFrame":"Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose"},{"measure":"Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN)","description":"PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\\[0-tau\\]) of Norelgestromin (NGMN)","timeFrame":"Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose"},{"measure":"Period 1 and Period 2, PK: Cmax of Norelgestromin (NGMN)","description":"PK: Cmax of Norelgestromin (NGMN)","timeFrame":"Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Overtly healthy females as determined by medical history, physical examination, and other screening procedures\n* Have a body mass index (BMI) equal to or above 18.5 kilograms per meter squared (kg/m²), at screening\n* Are not intending to start a family within 2 months after the study\n\nExclusion Criteria:\n\n* Have known allergies to either tirzepatide or ethinylestradiol or norgestimate or related compounds\n* Have a medical condition or medical history that precludes the taking of combined oral contraceptives\n* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors\n* Have used hormonal implants or received hormonal injections in the past 12 months\n* Unwilling to comply with smoking restrictions during the study\n* Is a known user of drugs of abuse","healthyVolunteers":true,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"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)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Covance Dallas","city":"Dallas","state":"Texas","zip":"75247","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Overall Study","description":"Lead In Period and Period 1:\n\nParticipants received a 28-day packet of a combination oral contraceptive (OC) containing 21 days of tablets that consist of active ingredients (0.035 mg ethinyl estradiol (EE) and 0.25 mg norgestimate (NGM)) self-administered orally once-daily (QD) on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day.\n\nPeriod 2:\n\nParticipants received a 28-day packet of a combination OC containing 21 days of tablets that consist of active ingredients (0.035 mg EE and 0.25 mg NGM) self-administered orally QD on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day and a single dose 5 mg tirzepatide administered subcutaneously (SC)."}],"periods":[{"title":"Lead In Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"40"}]},{"type":"Received at Least One Dose of OC","achievements":[{"groupId":"FG000","numSubjects":"40"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"38"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]},{"title":"Period 1","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"38"}]},{"type":"Received at Least One Dose of OC","achievements":[{"groupId":"FG000","numSubjects":"38"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"37"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]},{"title":"Period 2","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"37"}]},{"type":"Received at Least One Dose of OC","achievements":[{"groupId":"FG000","numSubjects":"37"}]},{"type":"Received at Least 1 Dose of Tirzepatide","achievements":[{"groupId":"FG000","numSubjects":"28"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"5"}]},{"type":"Dosing Termination by Sponsor","reasons":[{"groupId":"FG000","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All participants who received at least one dose of oral contraceptive or tirzepatide.","groups":[{"id":"BG000","title":"Overall Study","description":"Lead In Period and Period 1:\n\nParticipants received a 28-day packet of a combination OC containing 21 days of tablets that consist of active ingredients (0.035 mg EE and 0.25 mg NGM) self-administered QD on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day.\n\nPeriod 2:\n\nParticipants received a 28-day packet of a combination OC containing 21 days of tablets that consist of active ingredients (0.035 mg EE and 0.25 mg NGM) self-administered orally QD on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day and a single dose 5 mg tirzepatide administered SC."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"40"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33.6","spread":"7.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"40"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"23"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"17"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"18"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"20"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","calculatePct":false,"classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"40"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Period 1 and Period 2, Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Ethinylestradiol (EE)","description":"Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\\[0-tau\\]) of 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combination OC containing 21 days of tablets that consist of active ingredients (0.035 mg EE and 0.25 mg NGM) self-administered orally QD on Day 1 to Day 21, and 7 days of non-active tablets self-administer orally QD on Day 22 to Day 28 approximately the same time each day and a single dose 5 mg tirzepatide administered SC."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"966","spread":"40"},{"groupId":"OG001","value":"811","spread":"41"}]}]}]},{"type":"PRIMARY","title":"Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EE","description":"PK: Cmax of EE","populationDescription":"Period 1 and Period 2: All participants who received at least one dose of oral contraceptive or tirzepatide and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of 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administered SC."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"24"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"119","spread":"33"},{"groupId":"OG001","value":"49.6","spread":"63"}]}]}]},{"type":"PRIMARY","title":"Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN)","description":"PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC\\[0-tau\\]) of Norelgestromin (NGMN)","populationDescription":"Period 1 and Period 2: All participants who received at least one dose of oral contraceptive or tirzepatide and had evaluable PK data.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pg*h/mL","timeFrame":"Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours 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disorders","sourceVocabulary":"MedDRA 22.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":40},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":28}]},{"term":"Pain","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":40},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":28}]},{"term":"Corona virus infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":40},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":28}]},{"term":"Decreased appetite","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":40},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":38},{"groupId":"EG002","numEvents":6,"numAffected":6,"numAtRisk":28}]},{"term":"Back pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.1","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":40},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":28}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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