Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-01-25 @ 12:20 AM
Study NCT ID:
NCT00857961
Status:
COMPLETED
Last Update Posted:
2011-01-07
First Post:
2009-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations
Sponsor:
Organization:
Raw JSON
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'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '3 mL (30 mg) of 1% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).', 'otherNumAtRisk': 21, 'otherNumAffected': 4, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '1.5 mL (30 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to one axilla.', 'otherNumAtRisk': 21, 'otherNumAffected': 5, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3 mL (60 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).', 'otherNumAtRisk': 21, 'otherNumAffected': 6, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '4.5 mL (90 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).', 'otherNumAtRisk': 21, 'otherNumAffected': 5, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Catheter site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 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'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Skin burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL (30 mg) of 1% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG001', 'title': '1.5 mL (30 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to one axilla.'}, {'id': 'OG002', 'title': '3 mL (60 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG003', 'title': '4.5 mL (90 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).'}], 'classes': [{'title': 'Total Testosterone', 'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '24.00'}, {'value': '12.00', 'groupId': 'OG001', 'lowerLimit': '1.95', 'upperLimit': '23.93'}, {'value': '4.25', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '20.00'}, {'value': '15.98', 'groupId': 'OG003', 'lowerLimit': '1.92', 'upperLimit': '23.97'}]}]}, {'title': 'Dihydrotestosterone', 'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '24.00'}, {'value': '11.93', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '23.93'}, {'value': '4.25', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '24.00'}, {'value': '15.98', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '24.00'}]}]}, {'title': 'Free Testosterone', 'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '24.00'}, {'value': '12.00', 'groupId': 'OG001', 'lowerLimit': '1.95', 'upperLimit': '23.93'}, {'value': '4.25', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '20.00'}, {'value': '15.98', 'groupId': 'OG003', 'lowerLimit': '1.92', 'upperLimit': '23.97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received all four doses of testosterone MD-lotion.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL (30 mg) of 1% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG001', 'title': '1.5 mL (30 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to one axilla.'}, {'id': 'OG002', 'title': '3 mL (60 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG003', 'title': '4.5 mL (90 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).'}], 'classes': [{'title': 'Cmax', 'categories': [{'measurements': [{'value': '546', 'spread': '266', 'groupId': 'OG000'}, {'value': '430', 'spread': '259', 'groupId': 'OG001'}, {'value': '590', 'spread': '289', 'groupId': 'OG002'}, {'value': '626', 'spread': '264', 'groupId': 'OG003'}]}]}, {'title': 'Cmin', 'categories': [{'measurements': [{'value': '164', 'spread': '63', 'groupId': 'OG000'}, {'value': '171', 'spread': '59', 'groupId': 'OG001'}, {'value': '221', 'spread': '101', 'groupId': 'OG002'}, {'value': '238', 'spread': '135', 'groupId': 'OG003'}]}]}, {'title': 'Cavg (n=21, n=20, n=21, n=21)', 'categories': [{'measurements': [{'value': '338', 'spread': '100', 'groupId': 'OG000'}, {'value': '294', 'spread': '150', 'groupId': 'OG001'}, {'value': '389', 'spread': '152', 'groupId': 'OG002'}, {'value': '432', 'spread': '185', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL (30 mg) of 1% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG001', 'title': '1.5 mL (30 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to one axilla.'}, {'id': 'OG002', 'title': '3 mL (60 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG003', 'title': '4.5 mL (90 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).'}], 'classes': [{'title': 'Cmax', 'categories': [{'measurements': [{'value': '90.7', 'spread': '64.1', 'groupId': 'OG000'}, {'value': '69.4', 'spread': '58.6', 'groupId': 'OG001'}, {'value': '96.4', 'spread': '46.2', 'groupId': 'OG002'}, {'value': '98.6', 'spread': '46.1', 'groupId': 'OG003'}]}]}, {'title': 'Cmin', 'categories': [{'measurements': [{'value': '33.3', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '34.6', 'spread': '26.5', 'groupId': 'OG001'}, {'value': '47.8', 'spread': '29.4', 'groupId': 'OG002'}, {'value': '49.4', 'spread': '26.7', 'groupId': 'OG003'}]}]}, {'title': 'Cavg (n=21, n=20, n=21, n=21)', 'categories': [{'measurements': [{'value': '62.3', 'spread': '34.0', 'groupId': 'OG000'}, {'value': '53.0', 'spread': '45.4', 'groupId': 'OG001'}, {'value': '71.4', 'spread': '35.1', 'groupId': 'OG002'}, {'value': '76.5', 'spread': '35.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL (30 mg) of 1% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG001', 'title': '1.5 mL (30 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to one axilla.'}, {'id': 'OG002', 'title': '3 mL (60 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG003', 'title': '4.5 mL (90 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).'}], 'classes': [{'title': 'Cmax', 'categories': [{'measurements': [{'value': '14.6', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '15.9', 'spread': '7.8', 'groupId': 'OG002'}, {'value': '16.5', 'spread': '6.2', 'groupId': 'OG003'}]}]}, {'title': 'Cmin', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '2.7', 'groupId': 'OG002'}, {'value': '6.4', 'spread': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'Cavg n=21, n=20, n=21, n=21)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '3.9', 'groupId': 'OG002'}, {'value': '11.4', 'spread': '4.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received all four doses of testosterone MD-lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL (30 mg) of 1% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG001', 'title': '1.5 mL (30 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to one axilla.'}, {'id': 'OG002', 'title': '3 mL (60 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG003', 'title': '4.5 mL (90 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).'}], 'classes': [{'title': 'Total Testosterone', 'categories': [{'measurements': [{'value': '107', 'spread': '55', 'groupId': 'OG000'}, {'value': '84', 'spread': '34', 'groupId': 'OG001'}, {'value': '91', 'spread': '41', 'groupId': 'OG002'}, {'value': '92', 'spread': '36', 'groupId': 'OG003'}]}]}, {'title': 'Dihydrotestosterone', 'categories': [{'measurements': [{'value': '85', 'spread': '47', 'groupId': 'OG000'}, {'value': '68', 'spread': '25', 'groupId': 'OG001'}, {'value': '70', 'spread': '29', 'groupId': 'OG002'}, {'value': '65', 'spread': '24', 'groupId': 'OG003'}]}]}, {'title': 'Free Testosterone', 'categories': [{'measurements': [{'value': '107', 'spread': '55', 'groupId': 'OG000'}, {'value': '84', 'spread': '34', 'groupId': 'OG001'}, {'value': '91', 'spread': '41', 'groupId': 'OG002'}, {'value': '92', 'spread': '36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.', 'unitOfMeasure': 'percent fluctuation in concentration', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL (30 mg) of 1% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG001', 'title': '1.5 mL (30 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to one axilla.'}, {'id': 'OG002', 'title': '3 mL (60 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG003', 'title': '4.5 mL (90 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).'}], 'classes': [{'title': 'Total Testosterone', 'categories': [{'measurements': [{'value': '8111', 'spread': '2394', 'groupId': 'OG000'}, {'value': '7053', 'spread': '3594', 'groupId': 'OG001'}, {'value': '9332', 'spread': '3639', 'groupId': 'OG002'}, {'value': '10361', 'spread': '4436', 'groupId': 'OG003'}]}]}, {'title': 'Dihydrotestosterone', 'categories': [{'measurements': [{'value': '1496', 'spread': '816', 'groupId': 'OG000'}, {'value': '1271', 'spread': '1090', 'groupId': 'OG001'}, {'value': '1712', 'spread': '842', 'groupId': 'OG002'}, {'value': '1836', 'spread': '862', 'groupId': 'OG003'}]}]}, {'title': 'Free Testosterone', 'categories': [{'measurements': [{'value': '214', 'spread': '61', 'groupId': 'OG000'}, {'value': '183', 'spread': '74', 'groupId': 'OG001'}, {'value': '250', 'spread': '94', 'groupId': 'OG002'}, {'value': '275', 'spread': '111', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.', 'unitOfMeasure': 'h*ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received all four doses of testosterone-MD lotion. One study participant in the 30 mg of 2% testosterone MD-lotion was not included in any analyses dependent on testosterone/DHT concentration at 24 hours, such as AUC(0-24), Cavg, and comparison of the pre-dose with 24 hours post-dose, since a 24 hour blood sample was not collected.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '3 mL (30 mg) of 1% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG001', 'title': '1.5 mL (30 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to one axilla.'}, {'id': 'OG002', 'title': '3 mL (60 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla).'}, {'id': 'OG003', 'title': '4.5 mL (90 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).'}], 'classes': [{'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Non-Serious Adverse Events', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)', 'description': 'A listing of adverse events is located in the Reported Adverse Events module.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants received all four doses of testosterone-MD lotion.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days.\n\nAll study participants received each of the 4 study treatments:\n\n3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).\n\n1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.\n\n3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).\n\n4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days.\n\nAll study participants received each of the 4 study treatments:\n\n3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).\n\n1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.\n\n3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).\n\n4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla).'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.3', 'spread': '12.3', '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': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'spread': '3.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilograms/square meter (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average Baseline Testosterone', 'classes': [{'categories': [{'measurements': [{'value': '193.2', 'spread': '73.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nanograms per deciliter (ng/dL)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'dispFirstSubmitDate': '2010-09-13', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-06', 'studyFirstSubmitDate': '2009-03-04', 'dispFirstSubmitQcDate': '2010-09-13', 'resultsFirstSubmitDate': '2010-12-15', 'studyFirstSubmitQcDate': '2009-03-05', 'dispFirstPostDateStruct': {'date': '2010-09-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-06', 'studyFirstPostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Time of Maximal Concentration (Tmax)', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Tmax is the time at which the maximum concentration (Cmax) was attained during the 24 hour period on Day 7.'}, {'measure': 'Pharmacokinetics of Total Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Cmax is the maximum observed serum concentration of total testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.'}, {'measure': 'Pharmacokinetics of Dihydrotestosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Cmax is the maximum observed serum concentration of dihydrotestosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.'}, {'measure': 'Pharmacokinetics of Free Testosterone: Maximal Concentration (Cmax), Minimum Concentration (Cmin), and Average Concentration (Cavg)', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Cmax is the maximum observed serum concentration of free testosterone during the 24 hour period on Day 7. Cmin is the minimum observed serum concentration during the 24 hour period on Day 7. Cavg(0-24) is the average serum concentration calculated during the 24 hour period on Day 7. Calculated as the AUC(0-24) divided by 24 hours.'}, {'measure': 'Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Degree of Fluctuation (DF)', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Degree of fluctuation in serum concentration calculated as ((Cmax-Cmin)/Cavg) x 100%.'}, {'measure': 'Pharmacokinetics of Total Testosterone, Dihydrotestosterone, Free Testosterone: Area Under the Time Concentration Curve [AUC(0-24h)]', 'timeFrame': 'Day 7 (0, 2, 4, 8, 12, 16, 20, 24 hours) of each of the four 7 day cycles of treatment', 'description': 'Area under the serum concentration versus time curve was calculated using the linear trapezoidal rule from time 0 to 24 hours on Day 7.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Baseline through 7 days of each cycle of four treatments and follow-up (up to 38 days)', 'description': 'A listing of adverse events is located in the Reported Adverse Events module.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also assess safety of the product.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male study participants with a prior documented diagnosis of hypoandrogenism as evidenced by previously documented: Hypothalamic, pituitary or testicular disorder or a Serum testosterone less than or equal to 300 ng/dL\n* Were receiving, or in the investigator's opinion were eligible to receive treatment for hypoandrogenism\n* Body Mass Index (BMI) less than 35 kg/m\\^2\n* Passed the required laboratory and physical screening tests\n* Haemoglobin levels at screening greater than or equal to 13.0 g/dL\n* Adequate venous access on left or right arm\n* Able to communicate with study staff, understand the study information sheet and sign the written Informed Consent forms; willing to follow and comply with study procedures\n\nExclusion Criteria:\n\n* Any significant history of allergy and/or sensitivity to the drug products or their excipients, including any history of sensitivity to testosterone and/or sunscreens\n* Any clinically significant chronic illness or finding on screening physical exam and/or laboratory testing\n* Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal drug absorption\n* Men with suspected reversible hypoandrogenism (i.e. due to medications, stress)\n* Any man in whom testosterone therapy is contraindicated, which included those with:\n\n * Known or suspected carcinoma (or history of carcinoma) of the prostate or symptoms of benign prostatic hyperplasia and/or symptoms of lower urinary obstruction,\n * Known or suspected carcinoma (or history of carcinoma) of the breast,\n * Severe liver damage i.e. cirrhosis, hepatitis or liver tumours,\n * Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions,\n * Significant cerebrovascular or coronary artery disease,\n * Known or suspected sleep apnoea,\n * Hematocrit \\> 51%\n* Men with clinically significant prostate exam or clinically significant elevated serum prostate specific antigen (PSA) level, or age adjusted reference range of PSA values.\n* Current history of drug or alcohol abuse (more than 4 standard drinks per day and/or abnormal liver function tests 3 times the upper limit of the normal range values)\n* Men taking concomitant medications that affect sex hormone binding globulin (SHBG) or testosterone concentrations or metabolism, or that were cytochrome P450 inducers or inhibitors, anti-coagulants (warfarin), or diabetic medications (insulin), anti-histamines\n* Men involved in sport in which there was screening for anabolic steroids\n* Men with uncontrolled diabetes (hemoglobin A1c \\[HbA1c\\] greater than or equal to 10%)\n* Men taking any Investigational Product, or who had received an Investigational Product within 28 days prior to screening or 5 half-lives (whichever was the longer)\n* Any contraindication to blood sampling\n* Study participants who planned to have a surgical procedure during the course of the study\n* Study participants with a partner of child bearing potential who was not willing to use adequate contraception (i.e. condoms) for the duration of the study\n* Study participants whose partners were pregnant"}, 'identificationModule': {'nctId': 'NCT00857961', 'briefTitle': 'A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase II, Randomised, Four-way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered Dose (MD) Lotion® Formulations and Doses in Hypogonadal Men', 'orgStudyIdInfo': {'id': '14271'}, 'secondaryIdInfos': [{'id': 'MTE07', 'type': 'OTHER', 'domain': 'Acrux'}, {'id': 'I5E-MC-TSAG', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3 mL (30 mg) of 1% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments.', 'interventionNames': ['Drug: Testosterone MD-Lotion']}, {'type': 'EXPERIMENTAL', 'label': '1.5 mL (30 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to one axilla. All study participants are randomized to each of the 4 study treatments.', 'interventionNames': ['Drug: Testosterone MD-Lotion']}, {'type': 'EXPERIMENTAL', 'label': '3 mL (60 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days to both axilla (1.5 mL to each axilla). All study participants are randomized to each of the 4 study treatments.', 'interventionNames': ['Drug: Testosterone MD-Lotion']}, {'type': 'EXPERIMENTAL', 'label': '4.5 mL (90 mg) of 2% Testosterone MD-Lotion', 'description': 'Applied once daily for 7 days by three doses to both axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). All study participants are randomized to each of the 4 study treatments.', 'interventionNames': ['Drug: Testosterone MD-Lotion']}], 'interventions': [{'name': 'Testosterone MD-Lotion', 'type': 'DRUG', 'otherNames': ['LY900011', 'Axiron'], 'description': 'Administered Topically', 'armGroupLabels': ['1.5 mL (30 mg) of 2% Testosterone MD-Lotion', '3 mL (30 mg) of 1% Testosterone MD-Lotion', '3 mL (60 mg) of 2% Testosterone MD-Lotion', '4.5 mL (90 mg) of 2% Testosterone MD-Lotion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'city': 'New Britain', 'state': 'Connecticut', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.66121, 'lon': -72.77954}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-31- Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}