Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-01-01 @ 7:23 AM
Study NCT ID:
NCT00779103
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2008-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Histrelin Subcutaneous Implant in Children With Central Precocious Puberty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011629', 'term': 'Puberty, Precocious'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C029256', 'term': 'histrelin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials@Endo.com', 'phone': '800-462-3636', 'title': 'Saji Vijayan, MBBS', 'organization': 'Endo Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From start of 2nd implant period through end of 6th implant period up to 48 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Overall - Histrelin Subcutaneous Implant (50 mg)', 'description': 'Subcutaneous implant designed to deliver histrelin continously for 12 months.\n\nHistrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 31, 'seriousNumAtRisk': 31, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Implant Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pharyngitis Streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Agression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Luteinizing Hormone (LH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observed Value'}, {'id': 'OG001', 'title': 'Change From Baseline'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.244', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000'}, {'value': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Month 1, Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.302', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '1.111', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.247', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '1.173', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.225', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '1.227', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.266', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '1.170', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.247', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '1.108', 'groupId': 'OG001'}]}]}, {'title': 'Month 13, Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.216', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '1.217', 'groupId': 'OG001'}]}]}, {'title': 'Month 18, Visit 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.118', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '1.233', 'groupId': 'OG001'}]}]}, {'title': 'Month 24, Visit 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.124', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '1.228', 'groupId': 'OG001'}]}]}, {'title': 'Month 36, Visit 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.126', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.734', 'groupId': 'OG001'}]}]}, {'title': 'Month 42, Visit 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.119', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '0.842', 'groupId': 'OG001'}]}]}, {'title': 'Month 48, Visit 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.232', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.871', 'groupId': 'OG001'}]}]}, {'title': 'Month 54, Visit 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.272', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '1.402', 'groupId': 'OG001'}]}]}, {'title': 'Month 60, Visit 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.336', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.937', 'groupId': 'OG001'}]}]}, {'title': 'Month 66, Visit 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.100', 'groupId': 'OG001'}]}]}, {'title': 'Month 72, Visit 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.357', 'groupId': 'OG000'}, {'value': '0.26', 'spread': '0.237', 'groupId': 'OG001'}]}]}, {'title': '1 Month Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.81', 'spread': '0.952', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.958', 'groupId': 'OG001'}]}]}, {'title': '6 Month Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.66', 'spread': '2.463', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '2.410', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 6 Months Post Last Implant', 'description': 'The suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment.(LH suppression is defined as a peak LH \\< 4 mIU/mL following stimulation with the GnRH analog).', 'unitOfMeasure': 'MIU/ML', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Population'}, {'type': 'SECONDARY', 'title': 'Follicle Stimulating Hormone (FSH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observed Value'}, {'id': 'OG001', 'title': 'Change From Baseline'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.26', 'spread': '1.656', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.60', 'groupId': 'OG000'}, {'value': '-0.20', 'groupId': 'OG001'}]}]}, {'title': 'Month 1, Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.611', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '1.566', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.814', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '1.464', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.787', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '1.674', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.939', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '1.776', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.16', 'spread': '1.712', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '1.868', 'groupId': 'OG001'}]}]}, {'title': 'Month 13, Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.68', 'spread': '1.048', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '1.394', 'groupId': 'OG001'}]}]}, {'title': 'Month 18, Visit 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.81', 'spread': '1.142', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '1.668', 'groupId': 'OG001'}]}]}, {'title': 'Month 24, Visit 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.89', 'spread': '0.855', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '1.486', 'groupId': 'OG001'}]}]}, {'title': 'Month 36, Visit 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.91', 'spread': '1.146', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '1.027', 'groupId': 'OG001'}]}]}, {'title': 'Month 42, Visit 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.63', 'spread': '1.119', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '1.457', 'groupId': 'OG001'}]}]}, {'title': 'Month 48, Visit 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.55', 'spread': '1.199', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '1.619', 'groupId': 'OG001'}]}]}, {'title': 'Month 54, Visit 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.752', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '2.288', 'groupId': 'OG001'}]}]}, {'title': 'Month 60, Visit 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.50', 'spread': '0.741', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '1.573', 'groupId': 'OG001'}]}]}, {'title': 'Month 66, Visit 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.89', 'spread': '1.578', 'groupId': 'OG001'}]}]}, {'title': 'Month 72, Visit 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.24', 'spread': '0.369', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '1.257', 'groupId': 'OG001'}]}]}, {'title': '1 Month Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.04', 'spread': '2.125', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '1.792', 'groupId': 'OG001'}]}]}, {'title': '6 Month Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.96', 'spread': '1.411', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '1.040', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 6 Month Post Last Implant', 'description': 'The suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment.(LH suppression is defined as a peak LH \\< 4 mIU/mL following stimulation with the GnRH analog).', 'unitOfMeasure': 'MIU/ML', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Population'}, {'type': 'SECONDARY', 'title': 'Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observed Value'}, {'id': 'OG001', 'title': 'Change From Baseline'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.95', 'spread': '1.485', 'groupId': 'OG000'}]}]}, {'title': 'Month 1, Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.50', 'spread': '2.687', 'groupId': 'OG000'}, {'value': '-4.45', 'spread': '1.202', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.25', 'spread': '2.475', 'groupId': 'OG000'}, {'value': '-2.70', 'spread': '0.990', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.67', 'spread': '2.082', 'groupId': 'OG000'}, {'value': '2.55', 'spread': '3.606', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.15', 'spread': '2.616', 'groupId': 'OG000'}, {'value': '-2.80', 'spread': '1.131', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.00', 'spread': '4.243', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '2.758', 'groupId': 'OG001'}]}]}, {'title': 'Month 13, Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.00', 'groupId': 'OG000'}, {'value': '2.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 18, Visit 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.80', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '1.485', 'groupId': 'OG001'}]}]}, {'title': 'Month 24, Visit 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.90', 'spread': '4.384', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '2.899', 'groupId': 'OG001'}]}]}, {'title': 'Month 36, Visit 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.90', 'groupId': 'OG000'}, {'value': '-3.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 42, Visit 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.10', 'groupId': 'OG000'}, {'value': '-1.80', 'groupId': 'OG001'}]}]}, {'title': 'Month 48, Visit 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.30', 'groupId': 'OG000'}, {'value': '-2.60', 'groupId': 'OG001'}]}]}, {'title': 'Month 54, Visit 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.10', 'groupId': 'OG000'}, {'value': '-5.80', 'groupId': 'OG001'}]}]}, {'title': 'Month 60, Visit 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000'}, {'value': '-2.90', 'groupId': 'OG001'}]}]}, {'title': '6 Months Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.00', 'groupId': 'OG000'}, {'value': '7.10', 'groupId': 'OG001'}]}]}, {'title': '12 Months Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '130.00', 'groupId': 'OG000'}, {'value': '120.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 12 Months Post Last Implant', 'description': 'Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Testosterone suppression is defined as serum testosterone \\< 30.0 ng/dL (0.8 nmol/L) in boys following the induction of suppression. One black female participant age 8.9 years old had a testosterone value of 11ng/dL at visit 4 (month 6).', 'unitOfMeasure': 'NG/DL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Population'}, {'type': 'SECONDARY', 'title': 'DHEA Sulfate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observed Value'}, {'id': 'OG001', 'title': 'Change From Baseline'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.69', 'spread': '36.526', 'groupId': 'OG000'}]}]}, {'title': 'Month 3, Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.88', 'spread': '46.802', 'groupId': 'OG000'}, {'value': '11.67', 'spread': '15.281', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.92', 'spread': '36.739', 'groupId': 'OG000'}, {'value': '6.08', 'spread': '14.961', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.22', 'spread': '45.057', 'groupId': 'OG000'}, {'value': '12.16', 'spread': '15.085', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.34', 'spread': '48.207', 'groupId': 'OG000'}, {'value': '25.77', 'spread': '28.256', 'groupId': 'OG001'}]}]}, {'title': 'Month 13, Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.00', 'spread': '43.624', 'groupId': 'OG000'}, {'value': '23.42', 'spread': '23.178', 'groupId': 'OG001'}]}]}, {'title': 'Month 18, Visit 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.25', 'spread': '47.973', 'groupId': 'OG000'}, {'value': '27.79', 'spread': '20.381', 'groupId': 'OG001'}]}]}, {'title': 'Month 24, Visit 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.31', 'spread': '47.283', 'groupId': 'OG000'}, {'value': '32.08', 'spread': '34.599', 'groupId': 'OG001'}]}]}, {'title': 'Month 36, Visit 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.50', 'spread': '72.809', 'groupId': 'OG000'}, {'value': '37.45', 'spread': '50.794', 'groupId': 'OG001'}]}]}, {'title': 'Month 42, Visit 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.00', 'spread': '39.443', 'groupId': 'OG000'}, {'value': '14.00', 'spread': '28.537', 'groupId': 'OG001'}]}]}, {'title': 'Month 48, Visit 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.00', 'spread': '50.292', 'groupId': 'OG000'}, {'value': '36.56', 'spread': '39.313', 'groupId': 'OG001'}]}]}, {'title': 'Month 54, Visit 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.60', 'spread': '43.952', 'groupId': 'OG000'}, {'value': '31.67', 'spread': '22.723', 'groupId': 'OG001'}]}]}, {'title': 'Month 60, Visit 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.44', 'spread': '34.667', 'groupId': 'OG000'}, {'value': '53.14', 'spread': '25.635', 'groupId': 'OG001'}]}]}, {'title': 'Month 66, Visit 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.50', 'spread': '3.536', 'groupId': 'OG000'}, {'value': '40.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 72, Visit 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.00', 'spread': '4.243', 'groupId': 'OG000'}, {'value': '23.00', 'groupId': 'OG001'}]}]}, {'title': '6 Months Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114.25', 'spread': '50.692', 'groupId': 'OG000'}, {'value': '61.43', 'spread': '28.148', 'groupId': 'OG001'}]}]}, {'title': '12 Months Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '131.88', 'spread': '69.907', 'groupId': 'OG000'}, {'value': '71.00', 'spread': '53.492', 'groupId': 'OG001'}]}]}, {'title': '24 Months Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '195.00', 'spread': '98.995', 'groupId': 'OG000'}, {'value': '140.50', 'spread': '84.146', 'groupId': 'OG001'}]}]}, {'title': '36 Months Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '184.00', 'groupId': 'OG000'}, {'value': '119.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 36 Months Post Last Implant', 'description': 'DHEA=Dehydroepiandrosterone', 'unitOfMeasure': 'UG/DL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Population'}, {'type': 'SECONDARY', 'title': 'Estradiol (MS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Observed Value'}], 'classes': [{'title': 'Month 36, Visit 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.277', 'groupId': 'OG000'}]}]}, {'title': 'Month 42, Visit 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.307', 'groupId': 'OG000'}]}]}, {'title': 'Month 48, Visit 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.319', 'groupId': 'OG000'}]}]}, {'title': 'Month 54, Visit 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.289', 'groupId': 'OG000'}]}]}, {'title': 'Month 60, Visit 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.201', 'groupId': 'OG000'}]}]}, {'title': 'Month 66, Visit 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.106', 'groupId': 'OG000'}]}]}, {'title': 'Month 72, Visit 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.205', 'groupId': 'OG000'}]}]}, {'title': '6 Months Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.38', 'spread': '0.909', 'groupId': 'OG000'}]}]}, {'title': '12 Months Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': '2.810', 'groupId': 'OG000'}]}]}, {'title': '24 Months Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.70', 'spread': '0.424', 'groupId': 'OG000'}]}]}, {'title': '36 Months Post Last Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 36 - 36 Months Post Last Implant', 'description': 'Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Estradiol suppression is defined as serum estradiol in the assay specific range \\< 20 pg/mL (73 pmol/L) in girls following the induction of suppression.', 'unitOfMeasure': 'NG/DL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Population'}, {'type': 'SECONDARY', 'title': 'Estradiol (RIA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Observed Value'}, {'id': 'OG001', 'title': 'Change From Baseline'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.58', 'spread': '1.754', 'groupId': 'OG000'}]}]}, {'title': 'Day 1, Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 1, Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.199', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.775', 'groupId': 'OG001'}]}]}, {'title': 'Month 3, Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.160', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '1.765', 'groupId': 'OG001'}]}]}, {'title': 'Month 6, Visit 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '1.742', 'groupId': 'OG001'}]}]}, {'title': 'Month 9, Visit 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.114', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.794', 'groupId': 'OG001'}]}]}, {'title': 'Month 12, Visit 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.526', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '1.599', 'groupId': 'OG001'}]}]}, {'title': 'Month 13, Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.57', 'spread': '0.184', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '1.806', 'groupId': 'OG001'}]}]}, {'title': 'Month 18, Visit 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.154', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '1.670', 'groupId': 'OG001'}]}]}, {'title': 'Month 24, Visit 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.136', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '1.119', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - Month 24', 'description': 'Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Estradiol suppression is defined as serum estradiol in the assay specific range \\< 20 pg/mL (73 pmol/L) in girls following the induction of suppression.', 'unitOfMeasure': 'NG/DL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Population'}, {'type': 'SECONDARY', 'title': 'Average Number of Implants Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Histrelin Subcutaneous Implant (50 mg)', 'description': 'Subcutaneous implant designed to deliver histrelin continously for 12 months.\n\nHistrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant\n\nExtension Safety Population (Second \\& Third Implant)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'There were 2 implants received that were not removed during the study and were excluded from this analysis due to unknown duration of treatment.', 'unitOfMeasure': 'Implants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Population'}, {'type': 'SECONDARY', 'title': 'Average Mean Implant Duration by Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Histrelin Subcutaneous Implant (50 mg)', 'description': 'Subcutaneous implant designed to deliver histrelin continously for 12 months.\n\nHistrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant\n\nExtension Safety Population (Second \\& Third Implant)'}], 'classes': [{'categories': [{'measurements': [{'value': '12.62', 'spread': '0.469', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'There were 2 implants received that were not removed during the study and were excluded from this analysis due to unknown duration of treatment.', 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Population'}, {'type': 'SECONDARY', 'title': 'Summary of EN3326 Implantation and Explantations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Implanted'}, {'id': 'OG001', 'title': 'Removed'}], 'classes': [{'title': 'First Implant (Day 1, Visit 1)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Second Implant (Month 12, Visit 6)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Third Implant (Month 24, Visit 11)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Fourth Implant (Month 36, Visit 13)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Fifth Implant (Month 48, Visit 15)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Sixth Implant (Month 60, Visit 17)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 - Month 60', 'description': 'Once the female participants reached 11 years of age and the male participants reached 12 years of age or the investigator determined that subjects no longer required hormone suppression, participants underwent final explantation and were eligible to continue into an optional Long Term Follow Up Phase (Post Implant Treatment Phase) for up to 5 years. The purpose of the optional Long Term Follow Up Phase was to collect additional medical and developmental information, such as onset of menses and final adult height after hormone suppression was discontinued.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall - Histrelin Subcutaneous Implant (50 mg)', 'description': 'Subcutaneous implant designed to deliver histrelin continously for 12 months.\n\nHistrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Initial Phase (First Implant) - 36 Completed', 'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'Second & Third Implant', 'achievements': [{'comment': 'Initial Extension Phase/Extended Access Phase (Second and Third Implant) - 22 Completed', 'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Fourth Implant', 'achievements': [{'comment': 'Second Extension Phase (4th Implant with Yearly Implantations till no longer required): 11 Completed', 'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'No Treatment', 'achievements': [{'comment': 'Optional Long Term Follow-up Phase (No Treatment)', 'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Initial Phase (First Implant)', 'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Histrelin Subcutaneous Implant (50 mg)', 'description': 'Subcutaneous implant designed to deliver histrelin continously for 12 months.\n\nHistrelin Subcutaneous Implant: histrelin subcutaneous 50 mg implant\n\nExtension Safety Population (Second \\& Third Implant)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '1.54', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '134.18', 'spread': '12.947', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '38.12', 'spread': '11.835', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '20.66', 'spread': '3.541', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pretreatment with Prior GnRH Therapy', 'classes': [{'categories': [{'title': 'Pretreated', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Naïve', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Initial Extension Phase/Extended Access Phase (Second and Third Implant)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2008-10-22', 'resultsFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2008-10-23', 'lastUpdatePostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-15', 'studyFirstPostDateStruct': {'date': '2008-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Luteinizing Hormone (LH)', 'timeFrame': 'Baseline - 6 Months Post Last Implant', 'description': 'The suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment.(LH suppression is defined as a peak LH \\< 4 mIU/mL following stimulation with the GnRH analog).'}], 'secondaryOutcomes': [{'measure': 'Follicle Stimulating Hormone (FSH)', 'timeFrame': 'Baseline - 6 Month Post Last Implant', 'description': 'The suppression of gonadotropins (luteinizing hormone and follicle stimulating hormone) and gonadal sex steroids (estrogen in girls and testosterone in boys, respectively) on treatment.(LH suppression is defined as a peak LH \\< 4 mIU/mL following stimulation with the GnRH analog).'}, {'measure': 'Testosterone', 'timeFrame': 'Baseline - 12 Months Post Last Implant', 'description': 'Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Testosterone suppression is defined as serum testosterone \\< 30.0 ng/dL (0.8 nmol/L) in boys following the induction of suppression. One black female participant age 8.9 years old had a testosterone value of 11ng/dL at visit 4 (month 6).'}, {'measure': 'DHEA Sulfate', 'timeFrame': 'Baseline - 36 Months Post Last Implant', 'description': 'DHEA=Dehydroepiandrosterone'}, {'measure': 'Estradiol (MS)', 'timeFrame': 'Month 36 - 36 Months Post Last Implant', 'description': 'Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Estradiol suppression is defined as serum estradiol in the assay specific range \\< 20 pg/mL (73 pmol/L) in girls following the induction of suppression.'}, {'measure': 'Estradiol (RIA)', 'timeFrame': 'Baseline - Month 24', 'description': 'Long-term treatment with histrelin acetate suppresses the LH response to GnRH causing LH levels to decrease to prepubertal levels within 1 month of treatment. As a result, serum concentrations of sex steroids (estrogen or testosterone) also decrease. Estradiol suppression is defined as serum estradiol in the assay specific range \\< 20 pg/mL (73 pmol/L) in girls following the induction of suppression.'}, {'measure': 'Average Number of Implants Received', 'timeFrame': '12 months', 'description': 'There were 2 implants received that were not removed during the study and were excluded from this analysis due to unknown duration of treatment.'}, {'measure': 'Average Mean Implant Duration by Subject', 'timeFrame': '12 Months', 'description': 'There were 2 implants received that were not removed during the study and were excluded from this analysis due to unknown duration of treatment.'}, {'measure': 'Summary of EN3326 Implantation and Explantations', 'timeFrame': 'Day 1 - Month 60', 'description': 'Once the female participants reached 11 years of age and the male participants reached 12 years of age or the investigator determined that subjects no longer required hormone suppression, participants underwent final explantation and were eligible to continue into an optional Long Term Follow Up Phase (Post Implant Treatment Phase) for up to 5 years. The purpose of the optional Long Term Follow Up Phase was to collect additional medical and developmental information, such as onset of menses and final adult height after hormone suppression was discontinued.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['puberty', 'precocious puberty', 'early puberty', 'early onset puberty', 'histrelin', 'histrelin subcutaneous implant', 'implant therapy'], 'conditions': ['Central Precocious Puberty']}, 'referencesModule': {'references': [{'pmid': '25803268', 'type': 'DERIVED', 'citation': 'Silverman LA, Neely EK, Kletter GB, Lewis K, Chitra S, Terleckyj O, Eugster EA. Long-Term Continuous Suppression With Once-Yearly Histrelin Subcutaneous Implants for the Treatment of Central Precocious Puberty: A Final Report of a Phase 3 Multicenter Trial. J Clin Endocrinol Metab. 2015 Jun;100(6):2354-63. doi: 10.1210/jc.2014-3031. Epub 2015 Mar 24.'}, {'pmid': '24295437', 'type': 'DERIVED', 'citation': 'Neely EK, Silverman LA, Geffner ME, Danoff TM, Gould E, Thornton PS. Random unstimulated pediatric luteinizing hormone levels are not reliable in the assessment of pubertal suppression during histrelin implant therapy. Int J Pediatr Endocrinol. 2013 Dec 2;2013(1):20. doi: 10.1186/1687-9856-2013-20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.', 'detailedDescription': 'Thirty-two (32) patients will receive a histrelin subdermal implant under the anesthesia deemed appropriate by the administering physician. Ten-twelve (10-12) sites will enroll 2-3 patients per site. It is anticipated that half the patients will be receiving GnRH analog treatment and the other half will be treatment naïve. All patients will undergo selective PK sampling post-implantation to assess histrelin profile. At 12 months, provided that the patient continues to meet the safety and efficacy parameters, the original implant will be removed and the patient can receive a new implant. At 13 months, patients who receive new implants will be evaluated at the study site and administratively transferred to the initial extension study. At Month 24), the implants inserted at Month 12 will be removed. At this time, patients who have completed the initial extension study and who wish to continue therapy with the histrelin implant will be eligible to receive a new (ie, third) implant and to enter an additional 12-month extended access phase at the discretion of the investigator. At Month 36, the implants inserted at Month 24 for the Extended Access Phase will be removed. At this time, patients who have completed the Extended Access Phase and who wish to continue therapy with the histrelin implant will be eligible to receive a new (ie, fourth) implant and to enter the Long Term Extended Access Phase (referred to as the Implant Treatment Phase) at the discretion of the investigator. The purpose of this phase is to provide patients with the opportunity to continue to receive a new implant at the end of each 12-month period until the patient no longer requires hormone suppression. Once implant therapy is discontinued, all patients are eligible to enter the Long Term Follow Up Phase (Post Implant Phase) of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-treated or treatment naive patients with gonadotropin-dependent precocious puberty\n* Pre-treatment pubertal type response of LH to a stndard GnRH stimulation test before initiation of treatment\n\nExclusion Criteria:\n\n* Children who are less than 2 years of age at enrollment\n* Children whose chronological age is greater than 8 years (naive) and 10 years (pre-treated) for girls or 9 years (naive) and 11 years (pre-treated) for boys at the onset of the study'}, 'identificationModule': {'nctId': 'NCT00779103', 'briefTitle': 'Histrelin Subcutaneous Implant in Children With Central Precocious Puberty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': 'Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Children With Central Precocious Puberty', 'orgStudyIdInfo': {'id': 'EN3326-300Former03-CPP-HIS-300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Histrelin Subcutaneous Implant (50 mg)', 'description': 'Subcutaneous implant designed to deliver histrelin continously for 12 months.', 'interventionNames': ['Drug: Histrelin Subcutaneous Implant']}], 'interventions': [{'name': 'Histrelin Subcutaneous Implant', 'type': 'DRUG', 'otherNames': ['Supprelin LA', 'implant therapy', 'histrelin implant'], 'description': 'histrelin subcutaneous 50 mg implant', 'armGroupLabels': ['Histrelin Subcutaneous Implant (50 mg)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Erica A Eugster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine, 705 Riley Hosp Dr, Rm 5960 Indianapolis, IN 46202'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}