[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100169959":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":21,"locations":30,"responsibleParty":41,"collaborators":21,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":21,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":21,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":70,"whyStopped":21,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Tibotec Pharmaceuticals, Ireland","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"001","EXPERIMENTAL","35 µg ethinylestradiol and 1 mg norethindrone once daily for first 21 days in each OC cycle (2 OC cycles in total) + 150 mg capsule once daily for 10 days (Day12 till and including Day21) in 2nd OC cycle",[13,14],"Drug: TMC435","Drug: Ovysmen",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","TMC435","Type = exact number, unit = mg, number = 150, form = capsule, route = oral use. Capsule is taken once daily for 10 days (Day12 till and including Day21) in 2nd OC cycle.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Ovysmen","Type = exact number, unit = mg, number = 35µg\u002F1mg, form = tablet, route = oral use. 35 µg ethinylestradiol and 1 mg norethindrone once daily for first 21 days in each OC cycle (2 OC cycles in total)",[9],[27],{"name":28,"affiliation":5,"role":29},"Tibotec Pharmaceuticals, Ireland Clinical Trial","STUDY_DIRECTOR",[31],{"facility":21,"status":21,"city":32,"state":21,"zip":21,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":21},"Merksem","Belgium","BE",{"type":36,"coordinates":37},"Point",[38,39],4.44903,51.24623,{"lat":39,"lon":38},{"type":42,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100169959","phase-1-a-study-in-healthy-female-participants-investigating-the-effect-of-tmc435-on-the-pharmacokinetics-of-the-synthetic-hormones-of-the-oral-contraceptive-ovysmen-100169959",false,"NCT01486004","A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen","A Phase-I, Open-label Trial in Healthy Female Subjects to Investigate the Effect of TMC435 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone","Inclusion Criteria:\n\n* Participants must practicing a highly effective method of birth control before entry and agree to continue to use the same method throughout the study and for at least 30 days after last administration of study drug\n* non-smoker for a least 3 months prior to screening\n\nExclusion Criteria:\n\n* Women who are pregnant, breastfeeding, pre-menopausal or post-menopausal\n* A positive Human Immunodeficiency Virus (HIV)-1 or HIV-2 test at screening\n* A positive Hepatitis A, B and C test at screening\n* A clinical significant abnormal finding in the gynaecological examination",true,"FEMALE","18 Years","45 Years",{"count":55,"type":56},18,"ACTUAL","INTERVENTIONAL",[59],"PHASE1","The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol and norethindrone (administered once a day) and on the levels of progesterone, luteinizing hormone and follicle-stimulating hormone, in healthy female participants. Ethinlyestradiol and norethindrone are synthetic hormones, which constitute the oral contraceptive Ovysmen. Also the short-term safety and tolerability of the co-administration of TMC435 and Ovysmen will be studied. Steady-state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. A contraceptive is a method that prevents pregnancy.",[62],"Hepatitis C Virus",[62,18,64,65,66,67,68,69],"TMC435-TiDP16-C124","TMC435-C124","HCV","Hepatitis C","Hep C","Healthy participants","COMPLETED","2013-01-30",{"date":73,"type":74},"2013-01-31","ESTIMATED",{"date":76,"type":21},"2011-11",{"date":78,"type":56},"2012-01",{"name":5,"class":6},1]