Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-03-01 @ 8:43 AM
Study NCT ID:
NCT03209492
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2017-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016729', 'term': 'Leuprolide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 24', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Leuprorelin Acetate 22.5 mg', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.', 'otherNumAtRisk': 328, 'deathsNumAtRisk': 328, 'otherNumAffected': 6, 'seriousNumAtRisk': 328, 'deathsNumAffected': 4, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 328, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 328, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 328, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 328, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 328, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 328, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 328, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 20.1'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Had One or More Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprorelin Acetate 22.5 mg', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.27', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had One or More Adverse Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Leuprorelin Acetate 22.5 mg', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.74', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'Adverse drug reaction refers to adverse events related to the administered drug.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Leuprorelin Acetate 22.5 mg', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '333'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '328'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Case Report Forms Uncollected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 61 investigative sites in Japan, from 01 April 2016 to 01 December 2017.', 'preAssignmentDetails': 'Participants with a historical diagnosis of prostate cancer were enrolled. Participants received interventions as part of routine medical care.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Leuprorelin Acetate 22.5 mg', 'description': 'Usually, for adults, 22.5 mg of Leuprorelin Acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received interventions as part of routine medical care.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '79.1', 'spread': '6.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '328', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '328', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Duration between Diagnosis of Prostate Cancer and Study Start', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.15', 'spread': '49.296', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mean duration between the first diagnosis of prostate cancer and the start of the study was reported.', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '243', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '4', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with each score of ECOG Performance Status at the study start was reported. Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (\\>) 50% of waking hours. 3: Capable of limited self-care, confined to bed or chair \\>50% of waking hours. 4: Completely disabled, not capable of any self-care, totally confined to bed/chair.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants who Had Treated with Adjuvant Therapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Localized Prostate Cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Locally Advanced Prostate Cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Metastatic Prostate Cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Outpatient Care', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '328', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Predisposition to Hypersensitivity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had No Predisposition to Hypersensitivity', 'measurements': [{'value': '321', 'groupId': 'BG000'}]}, {'title': 'Had Predisposition to Hypersensitivity', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical Complications', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had No Presence of Medical Complications', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}, {'title': 'Had Presence of Medical Complications', 'measurements': [{'value': '219', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.', 'unitOfMeasure': 'Participants'}, {'title': 'Medical History of Thromboembolism', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Had No History of Thromboembolism', 'measurements': [{'value': '293', 'groupId': 'BG000'}]}, {'title': 'Had History of Thromboembolism', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants with or without medical history of thromboembolism was reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23.49', 'spread': '3.222', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'Kilogram per square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The number analyzed is the number of participants with data available for analysis.'}, {'title': 'Prior Treatment of LH-RH Agonists or Antagonist', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Not Treated with LH-RH Agonists or Antagonist', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Treated with LH-RH Agonists or Antagonist', 'measurements': [{'value': '297', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who had or had not treated with LH-RH agonists or antagonist for prostate cancer was reported.', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Treatment of Drugs for Prostate Cancer', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Not Treated with Drugs', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}, {'title': 'Treated with Drugs', 'measurements': [{'value': '178', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of participants who had or had not treated with drugs except LH-RH agonists or antagonist for prostate cancer was reported.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-09', 'size': 1129178, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-08T21:56', 'hasProtocol': True}, {'date': '2018-01-30', 'size': 755653, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-08T21:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2017-07-04', 'resultsFirstSubmitDate': '2018-11-30', 'studyFirstSubmitQcDate': '2017-07-04', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-08', 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Had One or More Adverse Events', 'timeFrame': 'Up to Week 24'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Had One or More Adverse Reactions', 'timeFrame': 'Up to Week 24', 'description': 'Adverse drug reaction refers to adverse events related to the administered drug.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.', 'detailedDescription': 'The drug being tested in this study is called Leuprorelin acetate (Leuplin PRO for Injection Kit 22.5 mg). Leuprorelin acetate is being tested to treat people who have prostate cancer.\n\nThis study will look at the safety in patients with prostate cancer receiving the drug in the routine clinical setting.\n\nThe study will enroll approximately 300 patients.\n\n• Leuprorelin acetate\n\nThis multi-center trial will be conducted in Japan.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of participants with a diagnosis of prostate cancer and received dose of Leuplin PRO for Injection Kit 22.5 mg/Leuprorelin acetate in the routine medical care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with prostate cancer will be included.\n\nExclusion Criteria:\n\n* Participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives'}, 'identificationModule': {'nctId': 'NCT03209492', 'briefTitle': 'Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"', 'orgStudyIdInfo': {'id': 'Leuprorelin-5002'}, 'secondaryIdInfos': [{'id': 'JapicCTI-163213', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Leuprorelin acetate', 'description': 'Usually, for adults, 22.5 mg of leuprorelin acetate is subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants will receive interventions as part of routine medical care.', 'interventionNames': ['Drug: Leuprorelin acetate']}], 'interventions': [{'name': 'Leuprorelin acetate', 'type': 'DRUG', 'otherNames': ['Leuplin PRO for Injection Kit 22.5 mg'], 'description': 'Leuplin PRO for Injection Kit 22.5 mg', 'armGroupLabels': ['Leuprorelin acetate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Takeda Selected Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}