Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-28 @ 7:48 PM
Study NCT ID:
NCT00975650
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2009-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
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': 'D013739', 'term': 'Testosterone'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nbryson@aceruspharma.com', 'phone': '1-416-679-0776', 'title': 'Dr. Nathan Bryson, Vice President, Scientific Affairs', 'organization': 'Acerus Pharmaceuticals Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment A', 'description': 'Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 5, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B', 'description': 'Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 6, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment C', 'description': 'Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment D', 'description': 'Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 6, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application Site Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 57, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serum Testosterone Ln-Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '6.25', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '6.41', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '6.54', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '6.36', 'spread': '0.37', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.', 'description': 'The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.'}, {'type': 'PRIMARY', 'title': 'Serum Testosterone Ln-AUCt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '8.80', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '8.90', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '8.95', 'spread': '0.29', 'groupId': 'OG002'}, {'value': '9.09', 'spread': '0.29', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.', 'unitOfMeasure': 'ng.h/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.'}, {'type': 'PRIMARY', 'title': 'Serum Testosterone Cavg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '287.10', 'spread': '76.42', 'groupId': 'OG000'}, {'value': '316.64', 'spread': '88.93', 'groupId': 'OG001'}, {'value': '336.11', 'spread': '100.76', 'groupId': 'OG002'}, {'value': '384.62', 'spread': '102.97', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.'}, {'type': 'PRIMARY', 'title': 'Serum Dihydrotestosterone Ln-Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '3.54', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '3.80', 'spread': '0.41', 'groupId': 'OG002'}, {'value': '3.44', 'spread': '0.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.'}, {'type': 'PRIMARY', 'title': 'Serum Dihydrotestosterone Ln-AUCt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '6.34', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '6.47', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '6.52', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '6.33', 'spread': '0.34', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.', 'unitOfMeasure': 'ng.h/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.'}, {'type': 'PRIMARY', 'title': 'Serum Dihydrotestosterone Cavg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '25.24', 'spread': '8.51', 'groupId': 'OG000'}, {'value': '28.97', 'spread': '11.41', 'groupId': 'OG001'}, {'value': '30.79', 'spread': '12.50', 'groupId': 'OG002'}, {'value': '24.69', 'spread': '8.46', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Cavg Within the Reference Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days'}], 'classes': [{'title': 'Testosterone', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}]}, {'title': 'Dihydrotestosterone', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Each period is 7 days', 'description': 'The percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants includes participants who completed the corresponding treatment and had sufficient plasma concentration data to calculate the PK parameter.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1', 'description': 'Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days;'}, {'id': 'FG001', 'title': 'Sequence 2', 'description': 'Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}, {'id': 'FG002', 'title': 'Sequence 3', 'description': 'Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days'}, {'id': 'FG003', 'title': 'Sequence 4', 'description': 'Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'All Subjects who were dosed.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'spread': '12.0', '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': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', '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': '53', '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': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-09', 'studyFirstSubmitDate': '2009-09-10', 'resultsFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2009-09-10', 'lastUpdatePostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-09', 'studyFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Testosterone Ln-Cmax', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.', 'description': 'The primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment or that of the active control, Androderm®.'}, {'measure': 'Serum Testosterone Ln-AUCt', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.'}, {'measure': 'Serum Testosterone Cavg', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.'}, {'measure': 'Serum Dihydrotestosterone Ln-Cmax', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.'}, {'measure': 'Serum Dihydrotestosterone Ln-AUCt', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.'}, {'measure': 'Serum Dihydrotestosterone Cavg', 'timeFrame': '0.0 (trough), 0.50, 1.0, 1.5, 2.0, 3.0, 6.0, 9.0, 10.0, 10.5, 11.0, 11.5, 12.0, 13.0, 16.0, 19.0, 22.0, and 24.0 hours.'}, {'measure': 'Percentage of Subjects With Cavg Within the Reference Range', 'timeFrame': 'Each period is 7 days', 'description': 'The percentage of subjects with a Cavg within the reference range of 300 to 1050 ng/dL and 25.5 to 97.8 ng/dL for testosterone and dihydotestosterone.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary Hypogonadism', 'Secondary Hypogonadism'], 'conditions': ['Hypogonadism']}, 'descriptionModule': {'briefSummary': 'This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.', 'detailedDescription': 'Primary Objective:\n\nThe primary objective of this study was to determine the efficacy of Nasobol in the treatment of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by establishing a pharmacokinetic profile for serum testosterone levels following Nasobol treatment, and comparing it to that of the active control, Androderm®.\n\nSecondary Objective:\n\nTo establish a safety profile for Nasobol.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes) testosterone levels \\>100 ng/dl and ≤ 300 ng/dL.\n* Normal Otolaryngological nasal endoscopy examination.\n* Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.\n\nExclusion Criteria:\n\n* Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex hormones\n* Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12 months\n* History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or sinus surgery.\n* History of nasal disorders (e.g. polyposis, recurrent epistaxis ( \\> 1 nose bleed per month, abuse of nasal decongestants) or sleep apnea.'}, 'identificationModule': {'nctId': 'NCT00975650', 'briefTitle': 'Efficacy and Tolerability of an Intra-Nasal Testosterone Product', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acerus Pharmaceuticals Corporation'}, 'officialTitle': 'Efficacy and Tolerability of Nasobol®, an Intra-Nasal Testosterone Product, for Testosterone Replacement in Hypogonadal Men', 'orgStudyIdInfo': {'id': 'Nasobol-01-2009'}, 'secondaryIdInfos': [{'id': 'TBS1-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test 8.0, Ref 5.0, Test 14.0, Test 11.0', 'description': 'Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days;', 'interventionNames': ['Drug: Nasobol®', 'Drug: Androderm® (Positive Control)']}, {'type': 'EXPERIMENTAL', 'label': 'Test 11.0, Test 8.0, Ref 5.0, Test 14.0', 'description': 'Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days', 'interventionNames': ['Drug: Nasobol®', 'Drug: Androderm® (Positive Control)']}, {'type': 'EXPERIMENTAL', 'label': 'Test 14.0, Test 11.0, Test 8.0, Ref 5.0', 'description': 'Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days;', 'interventionNames': ['Drug: Nasobol®', 'Drug: Androderm® (Positive Control)']}, {'type': 'EXPERIMENTAL', 'label': 'Ref 5.0, Test 14.0, Test 11.0, Test 8.0', 'description': 'Treatment D: 5.0 mg Androderm® (Positive Control)-Patch, q.d. for 7 days; Treatment C: 14.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment B: 11.0 mg Nasobol® (2 syringes), b.i.d. for 7 days; Treatment A: 8.0 mg Nasobol® (2 syringes), b.i.d. for 7 days', 'interventionNames': ['Drug: Nasobol®', 'Drug: Androderm® (Positive Control)']}], 'interventions': [{'name': 'Nasobol®', 'type': 'DRUG', 'description': 'Intra-nasal Testosterone (2 syringes), b.i.d.', 'armGroupLabels': ['Ref 5.0, Test 14.0, Test 11.0, Test 8.0', 'Test 11.0, Test 8.0, Ref 5.0, Test 14.0', 'Test 14.0, Test 11.0, Test 8.0, Ref 5.0', 'Test 8.0, Ref 5.0, Test 14.0, Test 11.0']}, {'name': 'Androderm® (Positive Control)', 'type': 'DRUG', 'description': 'QD administration', 'armGroupLabels': ['Ref 5.0, Test 14.0, Test 11.0, Test 8.0', 'Test 11.0, Test 8.0, Ref 5.0, Test 14.0', 'Test 14.0, Test 11.0, Test 8.0, Ref 5.0', 'Test 8.0, Ref 5.0, Test 14.0, Test 11.0']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Quality of Life Medical & Research centre', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Research', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '33169', 'city': 'Miami Gardens', 'state': 'Florida', 'country': 'United States', 'facility': 'Cetero Research', 'geoPoint': {'lat': 25.94204, 'lon': -80.2456}}, {'zip': '67221', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Clinical Research Institute', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Regional Urology, LLC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'dgd Research Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Paul Desjardins, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Trimel Biopharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acerus Pharmaceuticals Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}