[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491083":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":24,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Oregon Health and Science University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active CYP3A5 Allele","ACTIVE_COMPARATOR","Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals with active CYP3A5 alleles",[13],"Drug: Ulipristal acetate",{"label":15,"type":10,"description":16,"interventionNames":17},"Inactive CYP3A5 Allele","Ulipristal acetate 30mg orally x 1 dose with pharmacokinetic and pharmacodynamics testing in individuals without active CYP3A5 alleles",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Ulipristal acetate","Evaluating the pharmacodynamic and pharmacokinetic outcomes after 1 dose of Ulipristal acetate 30mg in individuals with and without active CYP3A5 alleles",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"ALISON EDELMAN, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Women's Health Research Unit Department of OB\u002FGYN","CONTACT","503-494-3666","whru@ohsu.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":24},"OHSU","RECRUITING","Portland","Oregon","97239","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-122.67621,45.52345,{"lat":48,"lon":47},{"type":28,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Alison Edelman","Professor, OB\u002FGYN",[54],{"name":55,"class":56},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100491083","phase-4-disparities-in-emergency-contraceptive-metabolism-dictate-efficacy-100491083",false,"NCT05674513","Disparities in Emergency Contraceptive Metabolism Dictate Efficacy","Inclusion Criteria:\n\n* Generally healthy women\n* Aged 18-40\n* regular menses (every 21-35 days) experiencing ovulatory cycles proven by a single progesterone level of 3 ng\u002FmL or greater during the luteal phase of the screening cycle.\n\nExclusion Criteria:\n\n* Pregnant, seeking pregnancy, or breastfeeding\n* Known allergy to study medication\n* Recent use of hormonal contraception\n* Irregular periods (\\\u003C21 days or \\>35 day cycles)\n* Routine use of nonsteroidal anti-inflammatory drugs\n* Metabolic disorders\n* Smoking\n* Any condition that would preclude the provision of informed consent\n* Using drugs (within 2 weeks of study enrollment) known to interfere with the metabolism of UPA as well as drugs known to be CYP3A4 inducers, inhibitors, or CYP3A drug substrates",true,"FEMALE","18 Years","40 Years",{"count":68,"type":69},140,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","The purpose of this study is to learn more about why some people are at greater risk for oral emergency contraceptive failure while others are not. The investigators want to learn if genetic differences impact the risk of emergency contraception failure.",[75],"Contraceptive Usage",[21,77],"Emergency contraception","2024-08-16",{"date":80,"type":81},"2024-08-19","ACTUAL",{"date":83,"type":81},"2023-01-09",{"date":85,"type":69},"2027-12-31",{"name":5,"class":6},1]