[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ibis Reproductive Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100606384","phase-4-the-misoprostol-only-regimen-evidence-study-100606384",false,"NCT07174856","The Misoprostol-Only Regimen Evidence Study","The Misoprostol-Only Regimen Evidence (MORE) Study: A Randomized Controlled Trial Comparing the Misoprostol-only Regimen Versus the Combined Mifepristone and Misoprostol Regimen for Medication Abortion","MORE","Inclusion Criteria:\n\n* Pregnancy of \\\u003C or = 77 days duration based on LMP or ultrasound\n* Positive pregnancy test (self-report or in-clinic)\n* Age: States without parental involvement laws : in-person patients ages 14 years and older; States with parental involvement or notification laws: 18 years or older\n* Willing and able to give informed consent\n* Willing to comply with study protocol\n* Willing to record requested information in the study surveys\n* English or Spanish speaking\n* Has a text message, email, or phone call capable device for survey completion\n* Understands and signs an Institutional Review Board (IRB) approved informed consent form prior to undergoing any study procedures or randomization\n\nExclusion Criteria:\n\n* concurrent participation in any other interventional trial\n* unwilling to comply with the study protocol and survey\u002Fvisit schedule\n* contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)\n* contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)\n* cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)\n* diagnosis of porphyria\n* known bleeding disorder or receiving anticoagulants\n* pregnancy with an IUD in place\n* diagnosis of pregnancy of unknown location (PUL), early pregnancy failure, incomplete or inevitable abortion (absent gestational sac and\u002For open cervical os)\n* possibility of ectopic pregnancy\n* known or suspected pelvic infection\n* Have issues or concerns (in the judgement of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.\n* Have previously participated in the study\n* Be a site staff member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member with delegated study responsibilities.","FEMALE","14 Years",{"count":20,"type":21},1900,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this study is to evaluate the effectiveness, non-inferiority, and side-effect profile of an updated misoprostol-only regimen, as compared to the combined mifepristone-misoprostol regimen, among people seeking medication abortion (MAB) through 77 days of pregnancy in telehealth and in-person settings. The investigators aim to evaluate this in both in-clinic and telehealth medication abortion care in the United States.\n\nThe main questions it aims to answer are:\n\n1. What proportion of pregnant people using an updated misoprostol-only medication abortion regimen have a complete abortion using just the prescribed pills?\n2. Is the updated misoprostol-only medication abortion regimen no more than 5% less effective (non-inferior) than the standard combined medication abortion regimen?\n3. What is the pattern of beta hCG decline following use of a misoprostol-only medication abortion through 77 days of pregnancy?\n\nParticipants will:\n\n* be randomized to one of two medication regimens (misoprostol-only or the combined regimen) in a 1:1 ratio based on duration of pregnancy at enrollment. - self-report outcomes via daily surveys for the first 3 days, and thereafter weekly at 7, 14, 21, 28, and 35 days.\n* return to the clinical site for tests as instructed\n\nThe investigators hypothesize that the proportion with complete abortions in the misoprostol-only arm will be non-inferior to the proportion with complete abortions in the combined regimen arm within a 5% margin of inferiority",[27],"Abortion, Medical",[29,30,31],"misoprostol","mifepristone","medication abortion","NOT_YET_RECRUITING","2025-10-03",{"date":35,"type":36},"2025-10-08","ACTUAL",{"date":38,"type":21},"2025-10-10",{"date":40,"type":21},"2027-03",{"name":42,"class":43},"Ibis Reproductive Health","OTHER",""]