Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT00395993
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2006-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}, {'id': 'D007505', 'term': 'Iron-Dextran Complex'}, {'id': 'D007501', 'term': 'Iron'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mfalone@luitpold.com', 'phone': '610-650-4200', 'title': 'Mark A. Falone, MD', 'organization': 'Luitpold Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '11 months', 'eventGroups': [{'id': 'EG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': "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", 'otherNumAtRisk': 230, 'otherNumAffected': 120, 'seriousNumAtRisk': 230, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Oral Iron Tablets', 'description': '325 mg tablets TID on Days 0 through Day 42', 'otherNumAtRisk': 226, 'otherNumAffected': 133, 'seriousNumAtRisk': 226, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 5}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Uterine hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pelvic inflammatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL", 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': "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"}, {'id': 'OG001', 'title': 'Oral Iron Tablets', 'description': '325 mg tablets TID on Days 0 through Day 42'}], 'classes': [{'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Any time between baseline and the end of study or time to intervention', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population defined as subjects from the Safety Population who received at least 1 dose of study medication, had average baseline hemoglobin, TSAT, and ferritin levels, had heavy uterine bleeding, and had at least 1 post-baseline hemoglobin assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': "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"}, {'id': 'FG001', 'title': 'Oral Iron Tablets', 'description': '325 mg tablets TID on Days 0 through Day 42'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}, {'groupId': 'FG001', 'numSubjects': '231'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '212'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'Hospitals and medical clinics'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '456', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': "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"}, {'id': 'BG001', 'title': 'Oral Iron Tablets', 'description': '325 mg tablets TID on Days 0 through Day 42'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '454', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'spread': '7.49', 'groupId': 'BG000'}, {'value': '39.5', 'spread': '7.63', 'groupId': 'BG001'}, {'value': '39.1', 'spread': '7.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '456', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '456', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '16 of the 246 subjects randomized to FCM were discontinued prior to dosing and 5 of the 231 subjects randomized to oral iron were discontinued prior to dosing.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 456}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2006-11-02', 'resultsFirstSubmitDate': '2013-09-16', 'studyFirstSubmitQcDate': '2006-11-03', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-16', 'studyFirstPostDateStruct': {'date': '2006-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL", 'timeFrame': 'Any time between baseline and the end of study or time to intervention'}]}, 'conditionsModule': {'keywords': ['anemia', 'heavy uterine bleeding', 'menorrhagia', 'Anemia secondary to heavy uterine bleeding'], 'conditions': ['Anemia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Gordon S, Hadley PE, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Iron Deficiency Anemia in Heavy Uterine Bleeding. Society for the Advancement of Blood Management 6th Annual Meeting 2007.'}, {'type': 'RESULT', 'citation': 'Gordon S, Hadley PE, Van Wyck DB, Mangione A. Iron Carboxymaltose, a New Intravenous Iron Agent for Iron Deficiency Anemia in Heavy Uterine Bleeding. American College of Obstetricians & Gynecologists: 108S 2007.'}, {'pmid': '18567277', 'type': 'RESULT', 'citation': 'Morrison J, Patel ST, Watson W, Zaidi QR, Mangione A, Goss TF. Assessment of the prevalence and impact of anemia on women hospitalized for gynecologic conditions associated with heavy uterine bleeding. J Reprod Med. 2008 May;53(5):323-30.'}, {'pmid': '18752459', 'type': 'RESULT', 'citation': 'James AH, Patel ST, Watson W, Zaidi QR, Mangione A, Goss TF. An assessment of medical resource utilization and hospitalization cost associated with a diagnosis of anemia in women with obstetrical bleeding in the United States. J Womens Health (Larchmt). 2008 Oct;17(8):1279-84. doi: 10.1089/jwh.2007.0605.'}, {'pmid': '19682342', 'type': 'DERIVED', 'citation': 'Van Wyck DB, Mangione A, Morrison J, Hadley PE, Jehle JA, Goodnough LT. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009 Dec;49(12):2719-28. doi: 10.1111/j.1537-2995.2009.02327.x. Epub 2009 Jul 22.'}]}, 'descriptionModule': {'briefSummary': 'This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding', 'detailedDescription': 'This is an open-label, randomized, Phase III, active-control, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects \\>/= 18 years of age\n* History of Heavy uterine bleeding\n* Hgb \\</= 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'}, 'identificationModule': {'nctId': 'NCT00395993', 'briefTitle': 'Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Regent, Inc.'}, 'officialTitle': 'Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding', 'orgStudyIdInfo': {'id': '1VIT04002/003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferric Carboxymaltose (FCM)', 'description': "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", 'interventionNames': ['Drug: Ferric Carboxymaltose (FCM)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ferrous Sulfate tablets', 'description': '325 mg tablets TID on Days 0 through Day 42', 'interventionNames': ['Drug: Ferrous Sulfate tablets']}], 'interventions': [{'name': 'Ferric Carboxymaltose (FCM)', 'type': 'DRUG', 'description': "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", 'armGroupLabels': ['Ferric Carboxymaltose (FCM)']}, {'name': 'Ferrous Sulfate tablets', 'type': 'DRUG', 'otherNames': ['Oral Iron Tablets'], 'description': '325 mg tablets TID on Days 0 through Day 42', 'armGroupLabels': ['Ferrous Sulfate tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19403', 'city': 'Norristown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Luitpold Pharmaceuticals, Inc.', 'geoPoint': {'lat': 40.1215, 'lon': -75.3399}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Regent, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}