[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100087378":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":24,"locations":29,"responsibleParty":43,"collaborators":24,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":24,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":24,"enrollmentInfo":55,"targetDuration":24,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":69,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"American Regent, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ferric Carboxymaltose (FCM)","EXPERIMENTAL","Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered",[13],"Drug: Ferric Carboxymaltose (FCM)",{"label":15,"type":16,"description":17,"interventionNames":18},"Ferrous Sulfate tablets","ACTIVE_COMPARATOR","325 mg tablets TID on Days 0 through Day 42",[19],"Drug: Ferrous Sulfate tablets",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":27},[15],[28],"Oral Iron Tablets",[30],{"facility":31,"status":24,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":24},"Luitpold Pharmaceuticals, Inc.","Norristown","Pennsylvania","19403","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-75.3399,40.1215,{"lat":41,"lon":40},{"type":44,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100087378","phase-3-comparison-of-the-safety-and-efficacy-of-intravenous-iron-versus-oral-iron-in-the-treatment-of-anemia-secondary-to-heavy-uterine-bleeding-100087378",true,"NCT00395993","Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding","Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding","Inclusion Criteria:\n\n* Female subjects \\>\u002F= 18 years of age\n* History of Heavy uterine bleeding\n* Hgb \\\u003C\u002F= 11\n* Practicing acceptable birth control\n* Demonstrate ability to understand and comply with protocol\n\nExclusion Criteria:\n\n* Known Hypersensitivity to oral or IV iron\n* Anemia other than iron deficiency anemia\n* Iron storage disorders\n* Initiation of treatment that may effect degree of heavy uterine bleeding\n* Anticipated need for surgery\n* Severe psychiatric disorder\n* Active infection\n* Positive Pregnancy test\n* Known Hep B or C or Active Hepatitis\n* Received investigational Drug within 30 days\n* Alcohol or drug abuse",false,"FEMALE","18 Years",{"count":56,"type":57},456,"ACTUAL","INTERVENTIONAL",[60],"PHASE3","This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding",[63],"Anemia",[65,66,67,68],"anemia","heavy uterine bleeding","menorrhagia","Anemia secondary to heavy uterine bleeding","COMPLETED","2018-01-22",{"date":72,"type":57},"2018-02-20",{"date":74,"type":24},"2005-05",{"date":76,"type":57},"2006-06",{"name":5,"class":6},1]