Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-22 @ 4:54 PM
Study NCT ID:
NCT00663793
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2008-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ORAL T-6: Oral Androgens in Man-6
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C109238', 'term': 'acyline'}, {'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D018120', 'term': 'Finasteride'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamory@u.washington.edu', 'phone': '206-616-1727', 'title': 'John K Amory, MD, MPH', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Testosterone Only', 'description': '(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.', 'otherNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Testosterone Plus Finasteride', 'description': '(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.', 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Decreased Libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated aspartate aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve-Serum T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Only', 'description': '(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.'}, {'id': 'OG001', 'title': 'Testosterone Plus Finasteride', 'description': '(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.'}], 'classes': [{'title': "external matrix 'immediate' release", 'categories': [{'measurements': [{'value': '143', 'spread': '47', 'groupId': 'OG000'}, {'value': '198', 'spread': '86', 'groupId': 'OG001'}]}]}, {'title': "external matrix 'fast' release", 'categories': [{'measurements': [{'value': '144', 'spread': '44', 'groupId': 'OG000'}, {'value': '384', 'spread': '273', 'groupId': 'OG001'}]}]}, {'title': "external matrix 'slow' release", 'categories': [{'measurements': [{'value': '162', 'spread': '60', 'groupId': 'OG000'}, {'value': '237', 'spread': '141', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon sign-rank', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A sample size of 8 per group was estimated to confer an 80% power to detect a 40% difference in testosterone AUC with a standard deviation of 20% at an alpha of 0.05'}], 'paramType': 'MEAN', 'timeFrame': '14 days', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve-serum DHT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Only', 'description': '(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.'}, {'id': 'OG001', 'title': 'Testosterone Plus Finasteride', 'description': '(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.'}], 'classes': [{'title': "external matrix 'immediate' release", 'categories': [{'measurements': [{'value': '36', 'spread': '13', 'groupId': 'OG000'}, {'value': '23', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': "external matrix 'fast' release", 'categories': [{'measurements': [{'value': '42', 'spread': '21', 'groupId': 'OG000'}, {'value': '26', 'spread': '12', 'groupId': 'OG001'}]}]}, {'title': "external matrix 'slow' release", 'categories': [{'measurements': [{'value': '39', 'spread': '16', 'groupId': 'OG000'}, {'value': '26', 'spread': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon sign-rank', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No power calculation was performed for this pilot study.'}], 'paramType': 'MEAN', 'timeFrame': '14-days', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve-E2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Only', 'description': '(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.'}, {'id': 'OG001', 'title': 'Testosterone Plus Finasteride', 'description': '(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.'}], 'classes': [{'title': "external matrix 'immediate' release", 'categories': [{'measurements': [{'value': '1812', 'spread': '405', 'groupId': 'OG000'}, {'value': '2241', 'spread': '783', 'groupId': 'OG001'}]}]}, {'title': "external matrix 'fast' release", 'categories': [{'measurements': [{'value': '1961', 'spread': '528', 'groupId': 'OG000'}, {'value': '2002', 'spread': '861', 'groupId': 'OG001'}]}]}, {'title': "external matrix 'slow' release", 'categories': [{'measurements': [{'value': '1944', 'spread': '652', 'groupId': 'OG000'}, {'value': '3129', 'spread': '1574', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Area-under-the-curve for serum estradiol', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'No power calculation was performed for this pilot study'}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'unitOfMeasure': 'nmol*h/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Testosterone Only', 'description': '(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.'}, {'id': 'FG001', 'title': 'Testosterone Plus Finasteride', 'description': '(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle WA, between April 2008-March 2009.', 'preAssignmentDetails': '19 participants recruited; 19 screened, 2 excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Testosterone Only', 'description': '(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.'}, {'id': 'BG001', 'title': 'Testosterone Plus Finasteride', 'description': '(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26', 'spread': '4', 'groupId': 'BG000'}, {'value': '28', 'spread': '8', 'groupId': 'BG001'}, {'value': '27', 'spread': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Estradiol', 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'spread': '16.1', 'groupId': 'BG000'}, {'value': '114', 'spread': '54', 'groupId': 'BG001'}, {'value': '92.0', 'spread': '35.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '178', 'spread': '5', 'groupId': 'BG000'}, {'value': '179', 'spread': '7', 'groupId': 'BG001'}, {'value': '178.5', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex Hormone Binding Globulin (SHBG)', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '32.5', 'spread': '19.6', 'groupId': 'BG001'}, {'value': '34', 'spread': '16.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Testosterone (T)', 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '16.8', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '15.65', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '83', 'spread': '18', 'groupId': 'BG000'}, {'value': '89', 'spread': '22', 'groupId': 'BG001'}, {'value': '86', 'spread': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-27', 'studyFirstSubmitDate': '2008-04-18', 'resultsFirstSubmitDate': '2010-06-25', 'studyFirstSubmitQcDate': '2008-04-18', 'lastUpdatePostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-27', 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve-Serum T', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve-serum DHT', 'timeFrame': '14-days'}, {'measure': 'Area Under the Curve-E2', 'timeFrame': '14 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Male Contraception', 'Hypogonadism', 'Testosterone'], 'conditions': ['Contraception', 'Hypogonadism']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Plymate SR "Male Hypogonadism" in Principles and Practice of Endocrinology and Metabolism (3rd. Ed). Ed. Kenneth Becker, pp:1125-1150'}, {'pmid': '15713724', 'type': 'BACKGROUND', 'citation': 'Amory JK, Bremner WJ. Oral testosterone in oil plus dutasteride in men: a pharmacokinetic study. J Clin Endocrinol Metab. 2005 May;90(5):2610-7. doi: 10.1210/jc.2004-1221. Epub 2005 Feb 15.'}, {'pmid': '16400081', 'type': 'BACKGROUND', 'citation': 'Amory JK, Page ST, Bremner WJ. Oral testosterone in oil: pharmacokinetic effects of 5alpha reduction by finasteride or dutasteride and food intake in men. J Androl. 2006 Jan-Feb;27(1):72-8. doi: 10.2164/jandrol.05058.'}, {'pmid': '15579744', 'type': 'BACKGROUND', 'citation': 'Herbst KL, Coviello AD, Page S, Amory JK, Anawalt BD, Bremner WJ. A single dose of the potent gonadotropin-releasing hormone antagonist acyline suppresses gonadotropins and testosterone for 2 weeks in healthy young men. J Clin Endocrinol Metab. 2004 Dec;89(12):5959-65. doi: 10.1210/jc.2003-032123.'}, {'pmid': '20378927', 'type': 'RESULT', 'citation': 'Snyder CN, Clark RV, Caricofe RB, Bush MA, Roth MY, Page ST, Bremner WJ, Amory JK. Pharmacokinetics of 2 novel formulations of modified-release oral testosterone alone and with finasteride in normal men with experimental hypogonadism. J Androl. 2010 Nov-Dec;31(6):527-35. doi: 10.2164/jandrol.109.009746. Epub 2010 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.', 'detailedDescription': 'This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (T), in normal men whose endogenous T production has been temporarily suppressed by the administration of the potent GnRH antagonist Acyline. We will be determining the relative pharmacokinetics of six different oral formulations of T in both rapid and slow release compared to the immediate release preparation studied previously by our group.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males between 18 to 50 years of age in good general health based on normal screening evaluation\n* must agree not to participate in another research drug study during participation\n* must agree to not donate blood during the study\n* must be willing to comply with the study protocol and procedures\n* must agree to use an acceptable form of contraception\n* agrees to not take medications other than the study drugs for the duration of the study\n\nExclusion Criteria:\n\n* Subject in poor health, determined by medical history physical and lab results\n* a known history or current use of alcohol, drug or steroid abuse and/or use of more than 3 alcohol beverages per day\n* Participation in a long-term contraceptive study within the past two months\n* History of bleeding disorders or current use of anti-coagulants\n* History of sleep apnea and/or major psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT00663793', 'acronym': 'ORAL-T-6', 'briefTitle': 'ORAL T-6: Oral Androgens in Man-6', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism', 'orgStudyIdInfo': {'id': '33738-B'}, 'secondaryIdInfos': [{'id': 'U54HD42456-06', 'type': 'OTHER_GRANT', 'domain': 'NIH/NICHD'}, {'id': 'K23HD045386', 'link': 'https://reporter.nih.gov/quickSearch/K23HD045386', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral testosterone', 'description': '(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.', 'interventionNames': ['Drug: Acyline', 'Drug: Testosterone']}, {'type': 'EXPERIMENTAL', 'label': 'Finasteride plus Oral Testosterone', 'description': '(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by "immediate release" T 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.', 'interventionNames': ['Drug: Acyline', 'Drug: Testosterone', 'Drug: Finasteride']}], 'interventions': [{'name': 'Acyline', 'type': 'DRUG', 'description': '300 mcg/kg', 'armGroupLabels': ['Finasteride plus Oral Testosterone', 'Oral testosterone']}, {'name': 'Testosterone', 'type': 'DRUG', 'otherNames': ['Oral Testosterone'], 'description': '24 hours after acyline administration on Day 2 "immediate release" Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by "external matrix fast release" T 300 mg once, followed 24 hours later (Day 4) by "external matrix slow release" T 300 mg once, followed 96 hours later (Day 8) by "immediate release" T 600 mg, followed 24 hours later (Day 9) by "external matrix fast release" T 600 mg po once, followed 48 hours later (Day 11) by "external matrix slow release" T 600 mg once.', 'armGroupLabels': ['Finasteride plus Oral Testosterone', 'Oral testosterone']}, {'name': 'Finasteride', 'type': 'DRUG', 'otherNames': ['Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo,', 'Prosteride, Gefina, Appecia, Finasterid IVAX, Finasterid Alternova,', 'Hyplafin, Penester, Finpros, Tectum, Prezepa'], 'description': '1 mg PO once daily \\[day -2 to day 12) 14 days total', 'armGroupLabels': ['Finasteride plus Oral Testosterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'John K Amory', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'John K Amory, MD, MPH', 'oldOrganization': 'University of Washington'}}}}