Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-27 @ 3:33 AM
Study NCT ID:
NCT00401193
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2006-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of XP12B in Women With Menorrhagia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}], 'ancestors': [{'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': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DK0-Disclosure@ferring.com', 'title': 'Clinical Development Support', 'organization': 'Ferring Pharmaceuticals'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '3900 mg/Day', 'description': 'Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation', 'otherNumAtRisk': 115, 'otherNumAffected': 97, 'seriousNumAtRisk': 115, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '1950 mg/Day', 'description': 'One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation', 'otherNumAtRisk': 115, 'otherNumAffected': 104, 'seriousNumAtRisk': 115, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation', 'otherNumAtRisk': 67, 'otherNumAffected': 56, 'seriousNumAtRisk': 67, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Muscle Cramps & Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Nasal & Sinus Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 7}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'seriousEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Ovarian Torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Reduction From Baseline in Menstrual Blood Loss (MBL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3900 mg/Day', 'description': 'Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation'}, {'id': 'OG001', 'title': '1950 mg/Day', 'description': 'One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '51', 'groupId': 'OG000'}, {'value': '44', 'spread': '57', 'groupId': 'OG001'}, {'value': '7', 'spread': '46', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline MBL over 3 menstrual cycles', 'description': 'reduction of menstrual blood loss in mL', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat population', 'anticipatedPostingDate': '2009-11'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3900 mg/Day', 'description': 'Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline scores over 3 menstrual cycles', 'description': 'A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)', 'anticipatedPostingDate': '2009-12'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3900 mg/Day', 'description': 'Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline scores over 3 menstrual cycles', 'description': 'A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)', 'anticipatedPostingDate': '2009-12'}, {'type': 'SECONDARY', 'title': 'Responder Analysis - Reduction in Large Stains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3900 mg/Day', 'description': 'Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline over 3 mentrual cycles', 'description': 'Percentage of subjects who experienced a reduction from baseline in the frequency of large stains', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat population (reflects those subjects who met the criteria for the primary efficacy analysis)', 'anticipatedPostingDate': '2009-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3900 mg/Day', 'description': 'Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation'}, {'id': 'FG001', 'title': '1950 mg/Day', 'description': 'One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'Intent to Treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'Modified Intent to Treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '106'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '297', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '3900 mg/Day', 'description': 'Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation'}, {'id': 'BG001', 'title': '1950 mg/Day', 'description': 'One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '6', 'groupId': 'BG000'}, {'value': '40', 'spread': '6', 'groupId': 'BG001'}, {'value': '39', 'spread': '6', 'groupId': 'BG002'}, {'value': '39', 'spread': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Intent to Treat Population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '297', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-23', 'studyFirstSubmitDate': '2006-11-09', 'resultsFirstSubmitDate': '2009-08-31', 'studyFirstSubmitQcDate': '2006-11-17', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-01', 'studyFirstPostDateStruct': {'date': '2006-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Reduction From Baseline in Menstrual Blood Loss (MBL)', 'timeFrame': 'Baseline MBL over 3 menstrual cycles', 'description': 'reduction of menstrual blood loss in mL'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding', 'timeFrame': 'Baseline scores over 3 menstrual cycles', 'description': 'A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited'}, {'measure': 'Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding', 'timeFrame': 'Baseline scores over 3 menstrual cycles', 'description': 'A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited'}, {'measure': 'Responder Analysis - Reduction in Large Stains', 'timeFrame': 'Baseline over 3 mentrual cycles', 'description': 'Percentage of subjects who experienced a reduction from baseline in the frequency of large stains'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Menorrhagia', 'Heavy Menstrual Bleeding'], 'conditions': ['Menorrhagia', 'Heavy Menstrual Bleeding']}, 'referencesModule': {'references': [{'pmid': '21777897', 'type': 'DERIVED', 'citation': 'Freeman EW, Lukes A, VanDrie D, Mabey RG, Gersten J, Adomako TL. A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding. Am J Obstet Gynecol. 2011 Oct;205(4):319.e1-7. doi: 10.1016/j.ajog.2011.05.015. Epub 2011 May 14.'}, {'pmid': '20942615', 'type': 'DERIVED', 'citation': 'Lukes AS, Muse K, Richter HE, Moore KA, Patrick DL. Estimating a meaningful reduction in menstrual blood loss for women with heavy menstrual bleeding. Curr Med Res Opin. 2010 Nov;26(11):2673-8. doi: 10.1185/03007995.2010.526098. Epub 2010 Oct 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with menorrhagia\n* 18-49 years of age\n* Regularly occurring menstrual periods\n\nExclusion Criteria:\n\n* History or presence of clinically significant disease or abnormalities that may confound the study\n* History of bilateral oophorectomy or hysterectomy\n* Hormone therapy for birth control'}, 'identificationModule': {'nctId': 'NCT00401193', 'briefTitle': 'Efficacy and Safety of XP12B in Women With Menorrhagia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia', 'orgStudyIdInfo': {'id': 'XP12B-MR-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Tranexamic acid tablets']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Tranexamic acid tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Placebo tablets']}], 'interventions': [{'name': 'Tranexamic acid tablets', 'type': 'DRUG', 'otherNames': ['Lysteda', 'XP12B'], 'description': '3900 mg/Day', 'armGroupLabels': ['1']}, {'name': 'Tranexamic acid tablets', 'type': 'DRUG', 'otherNames': ['Lysteda', 'XP12B'], 'description': '1950 mg/Day', 'armGroupLabels': ['2']}, {'name': 'Placebo tablets', 'type': 'DRUG', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72143', 'city': 'Searcy', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 35.25064, 'lon': -91.73625}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United 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