Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-28 @ 12:24 PM
Study NCT ID:
NCT01656161
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2012-07-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced 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': 'D017329', 'term': 'Triptorelin Pamoate'}], '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': 'eija.lundstrom@debiopharm.com', 'phone': '+41 21 321 06 03', 'title': 'Eija Lundstrom, Medical Director', 'organization': 'Debiopharm International'}, 'certainAgreement': {'otherDetails': 'Agreement restricts the PI from discussing or publishing trial results after the trial is completed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.', 'otherNumAtRisk': 120, 'otherNumAffected': 117, 'seriousNumAtRisk': 120, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 10}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 86}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic hyperglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meningitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paraparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.'}], 'classes': [{'title': 'Achieving (by Day 29)', 'categories': [{'measurements': [{'value': '98.33', 'groupId': 'OG000', 'lowerLimit': '94.11', 'upperLimit': '99.80'}]}]}, {'title': 'Maintaining (Day 57 to Day 337)', 'categories': [{'measurements': [{'value': '82.61', 'groupId': 'OG000', 'lowerLimit': '74.43', 'upperLimit': '89.04'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 337 days', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.'}], 'classes': [{'title': 'on Day 1 (n=118)', 'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '4.63'}]}]}, {'title': 'on Day 169 (n=115)', 'categories': [{'measurements': [{'value': '87.83', 'groupId': 'OG000', 'lowerLimit': '80.42', 'upperLimit': '93.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'on Days 1 and 169', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population with a measured value at the time analysed'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.'}], 'classes': [{'title': 'at Day 85 (n=119)', 'categories': [{'measurements': [{'value': '-83.20', 'spread': '38.10', 'groupId': 'OG000'}]}]}, {'title': 'at Day 169 (n=117)', 'categories': [{'measurements': [{'value': '-83.48', 'spread': '38.29', 'groupId': 'OG000'}]}]}, {'title': 'at Day 253 (n=114)', 'categories': [{'measurements': [{'value': '-85.43', 'spread': '33.94', 'groupId': 'OG000'}]}]}, {'title': 'at Day 337 (n=113)', 'categories': [{'measurements': [{'value': '-82.89', 'spread': '40.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through Day 337', 'unitOfMeasure': 'percentage of change in PSA levels', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population with a measured value at each specified time point'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Presented a Real "Acute-on-chronic" (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 171', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PK/PD Subset', 'description': 'Pharmacokinetic/pharmacodynamic (PK/PD) subset of 15 participants included in the ITT analysis set.'}], 'classes': [{'categories': [{'measurements': [{'value': '224.13', 'groupId': 'OG000', 'lowerLimit': '175.82', 'upperLimit': '285.72'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1-169', 'unitOfMeasure': 'day*nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PK/PD Subset', 'description': 'PK/PD subset of 15 participants included in the ITT analysis set.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.52', 'groupId': 'OG000', 'lowerLimit': '12.74', 'upperLimit': '21.41'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1-169', 'unitOfMeasure': 'nmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PK/PD Subset', 'description': 'PK/PD subset of 15 participants included in the ITT analysis set.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '40.02', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '48'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1-169', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK/PD subset of 15 participants'}, {'type': 'SECONDARY', 'title': 'Testosterone PD Metrics for First Injection: Time to Castration (Tcast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PK/PD Subset', 'description': 'PK/PD subset of 15 participants included in the ITT analysis set.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.01', 'groupId': 'OG000', 'lowerLimit': '16.45', 'upperLimit': '19.72'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1-169', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PK/PD Subset', 'description': 'PK/PD subset of 15 participants included in the ITT analysis set.'}], 'classes': [{'title': 'AUC(1-169)', 'categories': [{'measurements': [{'value': '61.30', 'groupId': 'OG000', 'lowerLimit': '53.50', 'upperLimit': '70.25'}]}]}, {'title': 'AUC(169-337)', 'categories': [{'measurements': [{'value': '66.44', 'groupId': 'OG000', 'lowerLimit': '58.99', 'upperLimit': '74.82'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1-169 and Days 169-337', 'unitOfMeasure': 'days * ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triptorelin PK Metrics for Both Injections: Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PK/PD Subset of 15 Participants', 'description': 'Pharmacokinetic/pharmacodynamic subset of 15 participants who received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.'}], 'classes': [{'title': 'Days 1-169', 'categories': [{'measurements': [{'value': '16.77', 'groupId': 'OG000', 'lowerLimit': '13.33', 'upperLimit': '21.09'}]}]}, {'title': 'Days 169-337', 'categories': [{'measurements': [{'value': '18.09', 'groupId': 'OG000', 'lowerLimit': '14.11', 'upperLimit': '23.20'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1-169 and Days 169-337', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Triptorelin PK Metrics for Both Injections: Concentration 0 Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PK/PD Subset', 'description': 'PK/PD subset of 15 participants included in the ITT analysis set.'}], 'classes': [{'title': 'Days 1-169', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.09'}]}]}, {'title': 'Days 169-337', 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.11'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1-169 and Days 169-337', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the PK/PD subset with a measured value.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Intention to treat analysis set', 'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'Received Triptorelin at Day 1', 'achievements': [{'comment': 'Safety analysis set', 'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'Received Triptorelin at Day 169', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Per protocol analysis set', 'groupId': 'FG000', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 10 hospital settings in South Africa, from 03 July 2012 to 30 August 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.23', 'spread': '7.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '120', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Africa', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set, defined as all enrolled subjects who received at least one dose of study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2012-07-31', 'resultsFirstSubmitDate': '2015-08-13', 'studyFirstSubmitQcDate': '2012-07-31', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-13', 'studyFirstPostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)', 'timeFrame': 'within 337 days'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169', 'timeFrame': 'on Days 1 and 169'}, {'measure': 'Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337', 'timeFrame': 'Baseline through Day 337'}, {'measure': 'Number of Participants Who Presented a Real "Acute-on-chronic" (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)', 'timeFrame': 'Day 171'}, {'measure': 'Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)', 'timeFrame': 'Days 1-169'}, {'measure': 'Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)', 'timeFrame': 'Days 1-169'}, {'measure': 'Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)', 'timeFrame': 'Days 1-169'}, {'measure': 'Testosterone PD Metrics for First Injection: Time to Castration (Tcast)', 'timeFrame': 'Days 1-169'}, {'measure': 'Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)', 'timeFrame': 'Days 1-169 and Days 169-337'}, {'measure': 'Triptorelin PK Metrics for Both Injections: Cmax', 'timeFrame': 'Days 1-169 and Days 169-337'}, {'measure': 'Triptorelin PK Metrics for Both Injections: Concentration 0 Hour', 'timeFrame': 'Days 1-169 and Days 169-337'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '10407987', 'type': 'BACKGROUND', 'citation': 'Klippel KF, Winkler CJ, Jocham D, Rubben H, Moser B, Gulati A. [Effectiveness and tolerance of 1 dosage forms (subcutaneous and intramuscular) of decapeptyl depot in patients with advanced prostate carcinoma]. Urologe A. 1999 May;38(3):270-5. doi: 10.1007/s001200050280. German.'}, {'pmid': '17096678', 'type': 'BACKGROUND', 'citation': 'Tornoe CW, Agerso H, Senderovitz T, Nielsen HA, Madsen H, Karlsson MO, Jonsson EN. Population pharmacokinetic/pharmacodynamic (PK/PD) modelling of the hypothalamic-pituitary-gonadal axis following treatment with GnRH analogues. Br J Clin Pharmacol. 2007 Jun;63(6):648-64. doi: 10.1111/j.1365-2125.2006.02820.x. Epub 2006 Nov 10.'}], 'seeAlsoLinks': [{'url': 'http://www.debiopharm.com', 'label': 'Company website'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in:\n\n* achieving castrate levels of testosterone (\\< 1.735 nmol/L) on Day 29 \\[i.e., 28 days after investigational medicinal product (IMP) injection\\], and\n* in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Summary Inclusion Criteria:\n\n* Meets protocol-specified criteria for qualification and contraception\n* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications\n* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures\n\nSummary Exclusion Criteria:\n\n* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters\n* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results"}, 'identificationModule': {'nctId': 'NCT01656161', 'briefTitle': 'Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer', 'orgStudyIdInfo': {'id': 'Debio 8206-SC-301'}, 'secondaryIdInfos': [{'id': 'KRA75538', 'type': 'OTHER', 'domain': 'Quintiles'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triptorelin embonate 22.5 mg', 'description': 'Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.', 'interventionNames': ['Drug: Triptorelin embonate 22.5 mg']}], 'interventions': [{'name': 'Triptorelin embonate 22.5 mg', 'type': 'DRUG', 'otherNames': ['Pamorelin'], 'armGroupLabels': ['Triptorelin embonate 22.5 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7646', 'city': 'Paarl', 'state': 'Cape Town, Western Cape', 'country': 'South Africa', 'facility': 'Paarl Medical Centre', 'geoPoint': {'lat': -33.73378, 'lon': 18.97523}}, {'zip': '7130', 'city': 'Somerset West', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'Vergelegen Medi-Clinic', 'geoPoint': {'lat': -34.08401, 'lon': 18.82113}}, {'zip': '7505', 'city': 'Tygerberg', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'Department of Urology, Tygerberg Hospital'}, {'zip': '6530', 'city': 'George', 'state': 'Eastern Cape', 'country': 'South Africa', 'facility': 'JCM Bahlmann'}, {'zip': '1475', 'city': 'Johannesburg', 'state': 'Gautang', 'country': 'South Africa', 'facility': 'East Rand Urology Research Unit, Clinix Private Clinic', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '1619', 'city': 'Kempton Park', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Clinresco Centres (Pty) Ltd', 'geoPoint': {'lat': -26.10859, 'lon': 28.2377}}, {'zip': '0002', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Clinical Trial Unit, Room 2-54, Prinshof Medical Campus', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0028', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Pretoria Urology Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '2571', 'city': 'Klerksdorp', 'state': 'North West', 'country': 'South Africa', 'facility': 'Wilmed Park Hospital', 'geoPoint': {'lat': -26.85213, 'lon': 26.66672}}, {'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'New Groote Schuur Hospital, Division of Urology', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Eija Lundstrom, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Debiopharm SA'}, {'name': 'J. Bahlmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Private Practitioner'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Debiopharm International SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quintiles, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}