[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100256359":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":40,"responsibleParty":181,"collaborators":39,"id":183,"slug":184,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":39,"eligibilityCriteria":189,"healthyVolunteers":185,"sex":190,"minAge":191,"maxAge":39,"enrollmentInfo":192,"targetDuration":39,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":39,"overallStatus":201,"whyStopped":202,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},{"fullName":5,"class":6},"Organon and Co","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ENG-E2 125 μg\u002F300 μg","EXPERIMENTAL","Participants will receive up to 13 cycles of ENG-E2 125 μg\u002F300 μg. Each cycle will consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.",[13],"Drug: ENG-E2 125 μg\u002F300 μg vaginal ring",{"label":15,"type":16,"description":17,"interventionNames":18},"LNG-EE 150 μg\u002F30 μg","ACTIVE_COMPARATOR","Participants will receive up to 13 cycles of LNG-EE 150 μg\u002F30 μg. Each cycle will consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.",[19],"Drug: LNG-EE 150 μg\u002F30 μg COC",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ENG-E2 125 μg\u002F300 μg vaginal ring","Up to 13 cycles of ENG-E2 125 μg\u002F300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.",[9],[27],"Etonogestrel + 17β-Estradiol Vaginal Ring",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"LNG-EE 150 μg\u002F30 μg COC","Up to 13 cycles of LNG-EE 150 μg\u002F30 μg administered orally, each cycle consisting of one tablet per day for 21 days, followed a 7-day tablet-free interval.",[15],[33],"Levonorgestrel-Ethinyl Estradiol COC",[35],{"name":36,"affiliation":37,"role":38},"Medical Director","Merck Sharp & Dohme LLC","STUDY_DIRECTOR",null,[41,52,62,71,81,91,101,111,121,131,141,151,161,171],{"facility":42,"status":39,"city":43,"state":39,"zip":39,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":39},"MSD Osterreich GmbH","Vienna","Austria","AT",{"type":47,"coordinates":48},"Point",[49,50],16.37208,48.20849,{"lat":50,"lon":49},{"facility":53,"status":39,"city":54,"state":39,"zip":39,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":39},"Merck Sharp & Dohme","San José","Costa Rica","CR",{"type":47,"coordinates":58},[59,60],-84.08489,9.93388,{"lat":60,"lon":59},{"facility":53,"status":39,"city":63,"state":39,"zip":39,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":39},"Glostrup Municipality","Denmark","DK",{"type":47,"coordinates":67},[68,69],12.40377,55.6666,{"lat":69,"lon":68},{"facility":72,"status":39,"city":73,"state":39,"zip":39,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":39},"MSD Finland Oy","Espoo","Finland","FI",{"type":47,"coordinates":77},[78,79],24.6522,60.2052,{"lat":79,"lon":78},{"facility":82,"status":39,"city":83,"state":39,"zip":39,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":90,"contacts":39},"Merck Sharp & Dohme GmbH","Haar","Germany","DE",{"type":47,"coordinates":87},[88,89],11.72653,48.10881,{"lat":89,"lon":88},{"facility":92,"status":39,"city":93,"state":39,"zip":39,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":39},"MSD Pharma Hungary Kft.","Budapest","Hungary","HU",{"type":47,"coordinates":97},[98,99],19.04045,47.49835,{"lat":99,"lon":98},{"facility":102,"status":39,"city":103,"state":39,"zip":39,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":39},"MSD Italia S.r.l.","Rome","Italy","IT",{"type":47,"coordinates":107},[108,109],12.51133,41.89193,{"lat":109,"lon":108},{"facility":112,"status":39,"city":113,"state":39,"zip":39,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":39},"MSD","Mexico City","Mexico","MX",{"type":47,"coordinates":117},[118,119],-99.12766,19.42847,{"lat":119,"lon":118},{"facility":122,"status":39,"city":123,"state":39,"zip":39,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":39},"Merck Sharp & Dohme BV","Haarlem","Netherlands","NL",{"type":47,"coordinates":127},[128,129],4.63683,52.38084,{"lat":129,"lon":128},{"facility":132,"status":39,"city":133,"state":39,"zip":39,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":39},"MSD Norge A\u002FS","Drammen","Norway","NO",{"type":47,"coordinates":137},[138,139],10.20449,59.74389,{"lat":139,"lon":138},{"facility":142,"status":39,"city":143,"state":39,"zip":39,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":39},"Merck Sharp & Dohme, Peru S.R.L.","Lima","Peru","PE",{"type":47,"coordinates":147},[148,149],-77.02824,-12.04318,{"lat":149,"lon":148},{"facility":152,"status":39,"city":153,"state":39,"zip":39,"country":154,"countryCode":155,"cosmosGeoPoint":156,"geoPoint":160,"contacts":39},"MSD Polska Sp. Z o.o.","Warsaw","Poland","PL",{"type":47,"coordinates":157},[158,159],21.01178,52.22977,{"lat":159,"lon":158},{"facility":162,"status":39,"city":163,"state":39,"zip":39,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":39},"MSD (Pty) LTD South Africa","Midrand","South Africa","ZA",{"type":47,"coordinates":167},[168,169],28.118,-25.976,{"lat":169,"lon":168},{"facility":172,"status":39,"city":173,"state":39,"zip":39,"country":174,"countryCode":175,"cosmosGeoPoint":176,"geoPoint":180,"contacts":39},"MSD Sweden","Stockholm","Sweden","SE",{"type":47,"coordinates":177},[178,179],18.06871,59.32938,{"lat":179,"lon":178},{"type":182,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100256359","phase-3-efficacy-and-safety-of-etonogestrel--17-estradiol-vaginal-ring-and-levonorgestrel-ethinyl-estradiol-combined-oral-contraceptive-in-adult-women-at-risk-for-pregnancy-mk-8342b-062-100256359",true,"NCT02616146","Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)","A Phase 3, Randomized, Active-Comparator Controlled Clinical Trial to Study the Contraceptive Efficacy and Safety of the MK-8342B (Etonogestrel + 17β-Estradiol) Vaginal Ring and the Levonorgestrel-Ethinyl Estradiol (LNG-EE) 150\u002F30 μg Combined Oral Contraceptive (COC) in Healthy Women 18 Years of Age and Older, at Risk for Pregnancy.","Inclusion Criteria:\n\n* Premenopausal female at risk for pregnancy and seeking contraception.\n* Willing to use a hormonal contraceptive vaginal ring for up to 13 treatment cycles, and not intending to use any other form of contraception.\n* Body mass index (BMI) of ≥18 and \\\u003C38 kg\u002Fm\\^2.\n* In good physical and mental health, based upon the medical judgment of the investigator.\n* Willing to adhere to use of vaginal ring and all required trial procedures.\n\nExclusion Criteria:\n\n* Cardiovascular risks and disorders, including history of venous thromboembolic \\[VTE\\] events, arterial thrombotic or thromboembolic \\[ATE\\] events, transient ischemic attack, angina pectoris, or claudication; at higher risk of VTE events due to recent prolonged immobilization, plans for surgery requiring prolonged immobilization, or a hereditary or acquired predisposition or elevated risk for venous or arterial thrombosis; currently smoking or uses tobacco\u002Fnicotine containing products and is ≥35 years of age; uncontrolled or severe hypertension; history of severe dyslipoproteinemia; \\\u003C35 years of age with a history of migraine with aura or focal neurological symptoms or ≥35 years of age with a history of migraines with or without aura or focal neurologic symptoms; diabetes mellitus with end-organ involvement or \\>20 years duration; multiple cardiovascular risk factors such as ≥35 years of age, obesity, inadequately controlled hypertension, use of tobacco\u002F nicotine products, or inadequately controlled diabetes.\n* Gastrointestinal disorders, including history of pancreatitis associated with severe hypertriglyceridemia; clinically significant liver disease, including active viral hepatitis or cirrhosis; history of malabsorptive bariatric surgery.\n* Other medical disorders, including history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer; any disease that may worsen under hormonal treatment such as disturbances in bile flow, systemic lupus erythematosus, pemphigoid gestationis or idiopathic icterus during previous pregnancy, middle-ear deafness, Sydenham chorea, or porphyria; known allergy\u002Fsensitivity or contraindication to the investigational products or their excipients; history of drug or alcohol abuse or dependence.\n* Recent, current, or suspected pregnancy; or has not had at least 2 menstrual cycles or has not completed two 28-day cycles of a hormonal contraceptive following a recent pregnancy; or is breastfeeding.\n* Gynecologic conditions: has gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis\u002Fcervicitis; has abnormal cervical Pap test or positive high-risk human papillomavirus (HPV) test at screening or documented within 3 years of screening; currently using an intrauterine device\u002Fintrauterine system (IUD\u002FIUS) or contraceptive implant; within past 6 months has had undiagnosed (unexplained) abnormal vaginal bleeding or any abnormal vaginal bleeding expected to recur during trial; has stage 4 pelvic organ prolapse (1 cm beyond introitus) or lesser degrees of prolapse with history of difficulty retaining tampons, vaginal rings, or other products within vagina.\n* Has used investigational drug and\u002For participated in other clinical trial within past 8 weeks.","FEMALE","18 Years",{"count":193,"type":194},2016,"ACTUAL","INTERVENTIONAL",[197],"PHASE3","The purpose of this study is to assess the contraceptive efficacy of the etonogestrel + 17β-estradiol (ENG-E2) vaginal ring in women between 18 and 35 years of age based on the number of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of ENG-E2 vaginal ring. The levonorgestrel-ethinyl estradiol (LNG-EE) 150\u002F30 μg combined oral contraceptive (COC) will be used as the active comparator.",[200],"Contraception","TERMINATED","Study terminated by Sponsor as a result of a business decision to discontinue the development program for MK-8342B for reasons unrelated to safety or efficacy.","2024-05-08",{"date":205,"type":194},"2024-05-17",{"date":207,"type":194},"2015-12-01",{"date":209,"type":194},"2016-10-06",{"name":5,"class":6},14]