[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100123466":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":30,"centralContacts":34,"locations":35,"responsibleParty":216,"collaborators":34,"id":218,"slug":219,"hasResults":220,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":34,"eligibilityCriteria":224,"healthyVolunteers":220,"sex":225,"minAge":226,"maxAge":34,"enrollmentInfo":227,"targetDuration":34,"studyType":230,"phases":231,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":238,"whyStopped":239,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":34,"completionDateStruct":34,"leadSponsor":244,"locationsCount":245},{"fullName":5,"class":6},"Repros Therapeutics Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"25 mg","EXPERIMENTAL","25 mg Proellex",[13],"Drug: Proellex",{"label":15,"type":10,"description":16,"interventionNames":17},"50 mg","50 mg Proellex",[13],[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Proellex","One 25mg capsule taken orally once every day.",[9],[25],"Telapristone acetate",{"type":20,"name":21,"description":27,"armGroupLabels":28,"otherNames":29},"Two 25mg capsules Proellex (50mg) taken orally once every day",[15],[25],[31],{"name":32,"affiliation":5,"role":33},"Andre van As, MD, PhD","STUDY_DIRECTOR",null,[36,49,59,69,78,88,98,108,113,123,133,143,152,162,174,183,189,195,201,207],{"facility":37,"status":34,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":34},"Genesis Center for Clinical Research","San Diego","California","92103","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-117.16472,32.71571,{"lat":47,"lon":46},{"facility":50,"status":34,"city":51,"state":52,"zip":53,"country":41,"countryCode":42,"cosmosGeoPoint":54,"geoPoint":58,"contacts":34},"Physician Care Clinical Research, LLC","Sarasota","Florida","34239",{"type":44,"coordinates":55},[56,57],-82.53065,27.33643,{"lat":57,"lon":56},{"facility":60,"status":34,"city":61,"state":62,"zip":63,"country":41,"countryCode":42,"cosmosGeoPoint":64,"geoPoint":68,"contacts":34},"Atlanta Women's Research Inst.","Atlanta","Georgia","30342",{"type":44,"coordinates":65},[66,67],-84.38798,33.749,{"lat":67,"lon":66},{"facility":70,"status":34,"city":71,"state":62,"zip":72,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":34},"Soapstone Center for Clinical Research","Decatur","30034",{"type":44,"coordinates":74},[75,76],-84.29631,33.77483,{"lat":76,"lon":75},{"facility":79,"status":34,"city":80,"state":81,"zip":82,"country":41,"countryCode":42,"cosmosGeoPoint":83,"geoPoint":87,"contacts":34},"York Clinical Consulting","Marrero","Louisiana","70072",{"type":44,"coordinates":84},[85,86],-90.10035,29.89937,{"lat":86,"lon":85},{"facility":89,"status":34,"city":90,"state":91,"zip":92,"country":41,"countryCode":42,"cosmosGeoPoint":93,"geoPoint":97,"contacts":34},"Female Pelvic Medicine","Grand Rapids","Michigan","49503",{"type":44,"coordinates":94},[95,96],-85.66809,42.96336,{"lat":96,"lon":95},{"facility":99,"status":34,"city":100,"state":101,"zip":102,"country":41,"countryCode":42,"cosmosGeoPoint":103,"geoPoint":107,"contacts":34},"Hawthorne Medical Research, Inc.","Winston-Salem","North Carolina","27103",{"type":44,"coordinates":104},[105,106],-80.24422,36.09986,{"lat":106,"lon":105},{"facility":109,"status":34,"city":100,"state":101,"zip":102,"country":41,"countryCode":42,"cosmosGeoPoint":110,"geoPoint":112,"contacts":34},"Lyndhurst Gynecologic Associates",{"type":44,"coordinates":111},[105,106],{"lat":106,"lon":105},{"facility":114,"status":34,"city":115,"state":116,"zip":117,"country":41,"countryCode":42,"cosmosGeoPoint":118,"geoPoint":122,"contacts":34},"Clinical Trials of America","Eugene","Oregon","97408",{"type":44,"coordinates":119},[120,121],-123.08675,44.05207,{"lat":121,"lon":120},{"facility":124,"status":34,"city":125,"state":126,"zip":127,"country":41,"countryCode":42,"cosmosGeoPoint":128,"geoPoint":132,"contacts":34},"Thomas Jefferson University - Jefferson Center for Women's Medical Specialties","Philadelphia","Pennsylvania","19107-5127",{"type":44,"coordinates":129},[130,131],-75.16362,39.95238,{"lat":131,"lon":130},{"facility":134,"status":34,"city":135,"state":136,"zip":137,"country":41,"countryCode":42,"cosmosGeoPoint":138,"geoPoint":142,"contacts":34},"Women's Care Center, PLC Research Memphis Associates","Memphis","Tennessee","38119",{"type":44,"coordinates":139},[140,141],-90.04898,35.14953,{"lat":141,"lon":140},{"facility":144,"status":34,"city":145,"state":136,"zip":146,"country":41,"countryCode":42,"cosmosGeoPoint":147,"geoPoint":151,"contacts":34},"Meharry Medical College","Nashville","37208",{"type":44,"coordinates":148},[149,150],-86.78444,36.16589,{"lat":150,"lon":149},{"facility":153,"status":34,"city":154,"state":155,"zip":156,"country":41,"countryCode":42,"cosmosGeoPoint":157,"geoPoint":161,"contacts":34},"Willowbend Health & Wellness Associates","Plano","Texas","75093",{"type":44,"coordinates":158},[159,160],-96.69889,33.01984,{"lat":160,"lon":159},{"facility":163,"status":34,"city":164,"state":165,"zip":166,"country":167,"countryCode":168,"cosmosGeoPoint":169,"geoPoint":173,"contacts":34},"Cepeme\u002FCerfahc","Curitiba","Paraná","80030-220","Brazil","BR",{"type":44,"coordinates":170},[171,172],-49.27306,-25.42778,{"lat":172,"lon":171},{"facility":175,"status":34,"city":176,"state":176,"zip":177,"country":167,"countryCode":168,"cosmosGeoPoint":178,"geoPoint":182,"contacts":34},"Brazilmed","São Paulo","01416-000",{"type":44,"coordinates":179},[180,181],-46.63611,-23.5475,{"lat":181,"lon":180},{"facility":184,"status":34,"city":176,"state":176,"zip":185,"country":167,"countryCode":168,"cosmosGeoPoint":186,"geoPoint":188,"contacts":34},"Universidade Federal de São Paulo - UNIFESP","04015-001",{"type":44,"coordinates":187},[180,181],{"lat":181,"lon":180},{"facility":190,"status":34,"city":176,"state":176,"zip":191,"country":167,"countryCode":168,"cosmosGeoPoint":192,"geoPoint":194,"contacts":34},"Hospital dos Servidores Públicos de SP","04039-901",{"type":44,"coordinates":193},[180,181],{"lat":181,"lon":180},{"facility":196,"status":34,"city":176,"state":176,"zip":197,"country":167,"countryCode":168,"cosmosGeoPoint":198,"geoPoint":200,"contacts":34},"Hospital Heliópolis","04230 - 000",{"type":44,"coordinates":199},[180,181],{"lat":181,"lon":180},{"facility":202,"status":34,"city":176,"state":176,"zip":203,"country":167,"countryCode":168,"cosmosGeoPoint":204,"geoPoint":206,"contacts":34},"Hospital Santa Marcelina","08270-070",{"type":44,"coordinates":205},[180,181],{"lat":181,"lon":180},{"facility":208,"status":34,"city":209,"state":34,"zip":210,"country":167,"countryCode":168,"cosmosGeoPoint":211,"geoPoint":215,"contacts":34},"Vox Femina","Jundiaí","13209-000",{"type":44,"coordinates":212},[213,214],-46.88417,-23.18639,{"lat":214,"lon":213},{"type":217,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100123466","phase-3-safety-and-efficacy-of-25-and-50-mg-doses-of-proellex-in-treating-the-recurrence-of-uterine-fibroid-symptoms-100123466",false,"NCT00874302","Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms","A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids","Inclusion Criteria:\n\n* At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)\n* Subject must have uterine fibroid-associated symptoms during the-screening visit\n* Subject has menstrual cycle lasting from 20 to 40 days\n* Other inclusion criteria may apply\n\nExclusion Criteria:\n\n* Post-menopausal women or women likely to become post-menopausal during the study\n* Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating\n* Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.\n* Subject who has had an acute illness within five days of study medication administration\n* Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically\n* Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)\n* Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening","FEMALE","18 Years",{"count":228,"type":229},0,"ACTUAL","INTERVENTIONAL",[232],"PHASE3","Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.",[235],"Uterine Fibroids",[237],"Uterine fibroids","WITHDRAWN","Study terminated for safety and the FDA put the study on hold for safety.","2014-06-26",{"date":242,"type":243},"2014-06-27","ESTIMATED",{"name":5,"class":6},20]