[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100189278":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":22,"centralContacts":22,"locations":22,"responsibleParty":29,"collaborators":22,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":22,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":22,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":22,"overallStatus":50,"whyStopped":22,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":59,"locationsCount":22},{"fullName":5,"class":6},"Repros Therapeutics Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Proellex 12 mg","EXPERIMENTAL","Telapristone acetate, 1 vaginally inserted capsule, once a day, for 4 months",[13],"Drug: Proellex 12 mg",{"label":15,"type":10,"description":16,"interventionNames":17},"Proellex 24 mg","Telapristone acetate, 1 vaginally inserted capsule, twice a day, for 4 months",[18],"Drug: Proellex 24 mg",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG",null,[9],[25],"telapristone acetate",{"type":21,"name":15,"description":22,"armGroupLabels":27,"otherNames":28},[15],[25],{"type":30,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100189278","phase-2-safety-pharmacokinetics-and-efficacy-of-proellex-telapristone-acetate-administered-vaginally-in-the-treatment-of-premenopausal-women-with-uterine-fibroids-who-have-completed-zpv-200-100189278",false,"NCT01739621","Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200","A Phase 2, Multi-Center, Extension Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200","Inclusion Criteria:\n\n* Have a negative pregnancy test at the Baseline visit\n* Subject has successfully completed ZPV-200 and demonstrated a return of menses\n\nExclusion Criteria:\n\n* Women with abnormally high liver enzymes or liver disease. Alanine aminotransferase(ALT) or aspartate aminotransferase (AST) exceeding 1.5x upper limit normal (ULN AND)total bilirubin exceeding 1.5x ULN at baseline and confirmed on repeat).\n* Clinically significant abnormal findings on baseline examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study","FEMALE","18 Years","47 Years",{"count":42,"type":43},40,"ESTIMATED","INTERVENTIONAL",[46],"PHASE2","To further determine the safety and efficacy of Proellex in premenopausal women with uterine fibroids who have previously completed study ZPV-200.",[49],"Uterine Fibroids","COMPLETED","2014-04-15",{"date":53,"type":43},"2014-04-16",{"date":55,"type":22},"2012-09",{"date":57,"type":58},"2014-04","ACTUAL",{"name":5,"class":6}]