[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553961":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":25,"responsibleParty":40,"collaborators":42,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":25,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":25,"overallStatus":70,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":25},{"fullName":5,"class":6},"Gynuity Health Projects","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Levonorgestrel plus mifepristone","EXPERIMENTAL","Women randomized to take one pill containing 1.5 mg levonorgestrel followed one to two days later by 200 mg mifepristone.",[13,14],"Drug: Levonorgestrel","Drug: Mifepristone",{"label":16,"type":10,"description":17,"interventionNames":18},"Placebo plus mifepristone","Women randomized to take one placebo pill followed one to two days later by 200 mg mifepristone.",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Levonorgestrel","Participants in the levonorgestrel plus mifepristone group will receive one tablet of 1.5 mg levonorgestrel",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Mifepristone","Participants in both groups will receive one tablet of 200 mg mifepristone",[9,16],[31],{"name":32,"affiliation":5,"role":33},"Beverly Winikoff, MD, MPH","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Manuel Bousieguez","CONTACT","212-448-1230","mbousieguez@gynuity.org",{"type":41,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[43,46],{"name":44,"class":45},"Cuidado Integral de la Mujer, Gineclinic, S.C.","UNKNOWN",{"name":47,"class":45},"Servicios de Salud Medieg, A. C","100553961","phase-2-assessing-the-efficacy-and-acceptability-of-two-missed-period-pills-regimens-100553961",false,"NCT06492889","Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens","Randomized Trial Comparing Progestin With Mifepristone Versus Mifepristone Alone for Use as Missed Period Pills","Inclusion Criteria:\n\n* Age 15-49 years\n* General good health\n* Does not want to be pregnant\n* History of regular monthly menstrual cycles (+\u002F- 3 days)\n* Missed menses of 2 to 8 days\n* Sexual activity in the past month\n* Willing and able to sign consent forms\n* Willing to return for a follow-up visit\n* Willing to provide urine sample at enrollment and follow-up\n\nExclusion Criteria:\n\n* Known allergies or contraindications to either study drug\n* Symptoms or risk factors for ectopic pregnancy\n* Current use of an IUD, contraceptive implant or injectable",true,"FEMALE","18 Years","49 Years",{"count":60,"type":61},286,"ESTIMATED","INTERVENTIONAL",[64,65],"PHASE2","PHASE3","The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. The second regimen will consist of one dose of a placebo pill, followed one to two days later by one dose of 200 mg mifepristone.\n\nThe investigators will assess and compare the efficacy of both regimens (proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment), and the effectiveness of both regimens (proportion of all participants not pregnant at follow-up among all participants enrolled)",[68,69],"Pregnancy Early","Pregnancy Related","NOT_YET_RECRUITING","2024-07-17",{"date":73,"type":74},"2024-07-18","ACTUAL",{"date":76,"type":61},"2024-07-22",{"date":78,"type":61},"2025-06-30",{"name":5,"class":6}]