Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT04274894
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2020-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality is reported from enrollment to 30 days after the last dose of study drug; the median time on follow-up was 176 days. TEAEs and SAEs were collected from the first dose of study drug until 30 days after the last dose of study drug; mean duration on study drug was 114 days.', 'eventGroups': [{'id': 'EG000', 'title': 'AndroGel 1.62%', 'description': 'AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.', 'otherNumAtRisk': 246, 'deathsNumAtRisk': 246, 'otherNumAffected': 43, 'seriousNumAtRisk': 246, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'DIVERTICULUM GASTRIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ABSCESS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19 PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'OTITIS EXTERNA CANDIDA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'OTITIS MEDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'LIP INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'SKIN LACERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'BLOOD PRESSURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'BLOOD PRESSURE SYSTOLIC INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HEART RATE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'LIVER FUNCTION TEST INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PROSTATIC SPECIFIC ANTIGEN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'GOUT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HYPERCHOLESTEROLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'TYPE 2 DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'SYNOVIAL CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PAROSMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'DYSURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'NIPPLE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PRIAPISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'DERMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'SKIN DISCOLOURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'SKIN EXFOLIATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COVID-19 PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'ISCHAEMIC STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AndroGel 1.62%', 'description': 'AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '8.99', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'LS Mean Change from Baseline to EOT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '0.63', 'ciUpperLimit': '3.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'groupDescription': 'The primary endpoint of change from Baseline to End of Treatment (EOT) in average 24-hour SBP was evaluated using a linear regression model with change in average 24-hour SBP from Baseline to EOT as the dependent variable, centralized baseline average 24-hour SBP, ongoing medical history of hypertension, and pooled study center as covariates in the per protocol population.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The hypothesis for the primary safety analysis is:\n\nH0: Change in 24-hour average SBP from Baseline to EOT ≥ 3 mmHg Vs. H1: Change in 24-hour average SBP from Baseline to EOT \\< 3 mmHg'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol set analysis: all participants who received at least 1 dose of study drug, were at least 85% compliant to study drug, and had valid Baseline and end of treatment systolic ABPM data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AndroGel 1.62%', 'description': 'AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COVID-19 infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}], 'preAssignmentDetails': 'All enrolled participants'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AndroGel 1.62%', 'description': 'AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '10.35', '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': '246', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '209', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS): all participants who received at least 1 dose of study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-26', 'size': 3949422, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-18T12:09', 'hasProtocol': True}, {'date': '2020-08-14', 'size': 448399, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-18T12:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-18', 'studyFirstSubmitDate': '2020-02-17', 'resultsFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-18', 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to End of Treatment (EOT) in 24-hour Average Systolic Blood Pressure (SBP)', 'timeFrame': 'Baseline, Week 16', 'description': 'Systolic blood pressure was measured by the ambulatory blood pressure monitoring (ABPM) procedure. Measurements were obtained from participants using a portable data-monitoring device. The ABPM procedure was performed over a 24-hour period across 2 days and included ABPM device application by site (1st Day) and ABPM device removal by site (2nd Day).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypogonadism', 'Testosterone Replacement Therapy', 'AndroGel'], 'conditions': ['Hypogonadism']}, 'referencesModule': {'references': [{'pmid': '39385523', 'type': 'DERIVED', 'citation': 'Weber MA, Aslam S, Efros MD, Chan A, Khan N, Li X, Dubcenco E, Miller MG. Single-arm study of testosterone gel replacement therapy and ambulatory blood pressure outcomes in men with hypogonadism. Andrology. 2025 Sep;13(6):1390-1401. doi: 10.1111/andr.13779. Epub 2024 Oct 9.'}], 'seeAlsoLinks': [{'url': 'https://www.rxabbvie.com/', 'label': 'Related Info.'}]}, 'descriptionModule': {'briefSummary': 'Hypogonadism is an endocrine disorder characterized by absent or deficient testosterone levels along with signs and symptoms of androgen deficiency, including delayed development or regression of sexual characteristics, impaired sexual function and sense of well-being, depressed mood, decreased muscle strength associated with loss of muscle mass and reduced bone mineral density. AndroGel 1.62% has demonstrated its ability to increase total testosterone levels in the blood by absorption of testosterone through the skin when applied topically. This study evaluated the effect of AndroGel 1.62% on systolic blood pressure using ambulatory blood pressure monitoring in hypogonadal men who used testosterone replacement therapy.\n\nAndroGel 1.62% is a drug used for the treatment of hypogonadism, which is associated with low or no testosterone. This was an open-label study which means that both the study doctor and study participants knew what drug and what dose is being used. All participants in this study were in the same group, called a treatment arm. Adult male participants with hypogonadism were enrolled and received AndroGel 1.62%. This was a multi-center study with 190 participants enrolled (initially planned) in approximately 45 sites in the United States to yield 171 subjects in the per protocol (PP) population. A blinded sample size re-estimation (BSSR) was performed when around 70% of the planned subjects in the PP population had completed the end of treatment visit. Sample size was increased at BSSR and 246 participants were actually enrolled.\n\nParticipants received daily topical gel doses of AndroGel 1.62% for approximately 16 weeks.\n\nThere may have been a higher burden for participants in this study compared to standard of care. Participants attended 8 study visits during the course of the study at a hospital or clinic and received 2 study phone calls. The effect of the treatment was checked by medical assessments, blood tests (including pharmacokinetic sampling), and 24-hour blood pressure monitors.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of hypogonadism with the presence of at least one of the following symptoms that may be related to low testosterone values and is/are consistent with hypogonadism:\n\n * Decreased sexual desire or libido\n * Decreased spontaneous erections (e.g. morning erections)\n * Decreased energy or fatigue/feeling tired\n * Low mood or depressed mood\n * Loss of body (axillary and pubic) hair or reduced shaving\n * Hot flashes AND\n* Confirmed by 2 serum testosterone levels \\< 300 ng/dL by blood samples drawn at least 48 hours apart. These samples should be obtained between 5 am and 11 am local time.\n* Blood pressure \\>100/60 mmHg and \\<140/90 mmHg\n\nExclusion Criteria:\n\n* Unprovoked deep vein thrombosis (DVT), unprovoked pulmonary embolism (PE), or known thrombophilia\n* Polycythemia vera or secondary polycythemia, such as polycythemia due to untreated sleep apnea or severe chronic obstructive pulmonary disease\n* Prostate or breast cancer\n* Any active malignancy\n* Clinically significant medical conditions or any other reason that the investigator determines would interfere with participation in this study or would make the participant an unsuitable candidate to receive study drug\n* Work night shifts or is otherwise required to perform strenuous manual labor while wearing the Ambulatory Blood Pressure Monitor (ABPM).'}, 'identificationModule': {'nctId': 'NCT04274894', 'briefTitle': 'A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': '24-Hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Receiving Testosterone Replacement Therapy', 'orgStudyIdInfo': {'id': 'M19-161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AndroGel 1.62%', 'description': 'AndroGel 1.62% was applied topically once daily in the morning beginning at the Day 1 Visit after confirmed valid ambulatory blood pressure monitoring (ABPM) assessment and was applied at approximately the same time each day after that during the study, for approximately 16 weeks. The starting dose of AndroGel 1.62% was 40.5 mg of T (2 pump actuations, applied to the upper arms and shoulders) and was titrated up or down by 20.25 mg or remained the same as assessed by morning serum T levels at Weeks 2 and 4.', 'interventionNames': ['Drug: AndroGel 1.62%']}], 'interventions': [{'name': 'AndroGel 1.62%', 'type': 'DRUG', 'otherNames': ['Testosterone gel'], 'description': 'AndroGel 1.62% was packaged in pump bottles with quantities sufficient to accommodate study design and could have been dose adjusted between a minimum of 20.25 mg of T (1 pump actuation) and a maximum of 81.0 mg of testosterone (4 pump actuations). For the first study drug administration at the Day 1 Visit, and also at Week 2, Week 4, Week 16 ambulatory blood pressure monitoring (ABPM,) and End of Treatment Visits, participants applied the study drug while on site so that the site staff could observe the proper administration of study drug. If participants forgot to apply their AndroGel 1.62% dose at their regularly scheduled dosing time, they were to take the next dose at the next dosing time.', 'armGroupLabels': ['AndroGel 1.62%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'G & L Research, LLC /ID# 216793', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '92663-3600', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'NewportNativeMD, Inc. /ID# 216992', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '91324-4622', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Valley Renal Medical Group Research /ID# 216321', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '94582', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Research LLC /ID# 216813', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Lynn Institute of Denver /ID# 216863', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33756-2004', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Research of West Florida /ID# 216364', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33484-6529', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Seidman Clinical Trials,Delray /ID# 216794', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Invesclinic, U.S., LLC /ID# 216778', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33012-4170', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research and Health Cen /ID# 216319', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32277', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Care Partners Clinical Research /ID# 216773', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pharmax Research Clinic /ID# 216343', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Care Research center Inc. /ID# 216367', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34761-4547', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'West Orange Endocrinology /ID# 217106', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '30189', 'city': 'Woodstock', 'state': 'Georgia', 'country': 'United States', 'facility': 'North Georgia Clinical Research /ID# 216864', 'geoPoint': {'lat': 34.10149, 'lon': -84.51938}}, {'zip': '83646', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Solaris Clinical Research /ID# 216772', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '60644', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loretto Hospital.Affnity Clinical Research Institute /ID# 216884', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60523-1245', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Affinity Clinical Research /ID# 216807', 'geoPoint': {'lat': 41.83281, 'lon': -87.92895}}, {'zip': '46036-3341', 'city': 'Elwood', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigative Clinical Research of Indiana, LLC /ID# 216943', 'geoPoint': {'lat': 40.27698, 'lon': -85.84192}}, {'zip': '50265', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Diabetes and Endocrinology Research Center /ID# 216316', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'PRN Professional Research Network of Kansas, LLC /ID# 216805', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40503-2969', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Research Grp of Lexington /ID# 216451', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21075', 'city': 'Elkridge', 'state': 'Maryland', 'country': 'United States', 'facility': 'Centennial Medical Group /ID# 216340', 'geoPoint': {'lat': 39.21261, 'lon': -76.71358}}, {'zip': '89123', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Advanced Biomedical Research of America /ID# 216797', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07059', 'city': 'Warren Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Amici Clinical Research /ID# 216779', 'geoPoint': {'lat': 40.60822, 'lon': -74.51803}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'NM Clinical Research & Osteoporosis Center, Inc /ID# 216808', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'AccuMed Research Associates /ID# 216775', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '27203', 'city': 'Asheboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Randolph Health Internal Medicine /ID# 216366', 'geoPoint': {'lat': 35.70791, 'lon': -79.81364}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OnSite Clinical Solutions, LLC /ID# 216279', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OnSite Clinical Solutions, LLC /ID# 216368', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27410', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Triad Clinical Trials /ID# 216792', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lucas Research /ID# 216487', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Diabetes and Endocrinology Associates of Stark County Inc /ID# 216362', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Intend Research /ID# 216320', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '19114-1025', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Tristar Clinical Investigations PC /ID# 216944', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15478', 'city': 'Smithfield', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Frontier Clinical Research /ID# 216365', 'geoPoint': {'lat': 39.80313, 'lon': -79.80783}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'New Phase Research & Development /ID# 216774', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions - Memphis /ID# 216790', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Family Research Center, Inc /ID# 216363', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '77027-3103', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Associates in Medicine, P.A. /ID# 216781', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76550', 'city': 'Lampasas', 'state': 'Texas', 'country': 'United States', 'facility': 'FMC Science /ID# 216318', 'geoPoint': {'lat': 31.06378, 'lon': -98.1817}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Discovery Clinical Trials-San Antonio /ID# 216866', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Northwest Houston Clinical Research PLLC /ID# 216358', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '22015-2234', 'city': 'Burke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Burke Internal Medicine & Research /ID# 216322', 'geoPoint': {'lat': 38.79345, 'lon': -77.27165}}, {'zip': '20110-4421', 'city': 'Manassas', 'state': 'Virginia', 'country': 'United States', 'facility': 'Manassas Clinical Research Center /ID# 216313', 'geoPoint': {'lat': 38.75095, 'lon': -77.47527}}, {'zip': '23114-3256', 'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Research Center /ID# 216341', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}