Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT01725451
Status:
COMPLETED
Last Update Posted:
2014-10-16
First Post:
2012-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D043343', 'term': 'Testosterone Propionate'}, {'id': 'D003836', 'term': 'Deodorants'}], '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': 'D003358', 'term': 'Cosmetics'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, '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': 'Testosterone Unshaved', 'description': 'No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.', 'otherNumAtRisk': 29, 'otherNumAffected': 3, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Testosterone Unshaved + Deodorant Spray', 'description': 'Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.', 'otherNumAtRisk': 29, 'otherNumAffected': 1, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Testosterone Unshaved + Deodorant Antiperspirant Spray', 'description': 'Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.', 'otherNumAtRisk': 29, 'otherNumAffected': 2, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Testosterone Unshaved + Deodorant Antiperspirant Stick', 'description': 'Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.', 'otherNumAtRisk': 28, 'otherNumAffected': 4, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Testosterone Shaved', 'description': 'No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Testosterone Shaved + Deodorant Antiperspirant Spray', 'description': 'Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Unshaved', 'description': 'No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.'}, {'id': 'OG001', 'title': 'Testosterone Unshaved + Deodorant Spray', 'description': 'Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.'}, {'id': 'OG002', 'title': 'Testosterone Unshaved + Deodorant Antiperspirant Spray', 'description': 'Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.'}, {'id': 'OG003', 'title': 'Testosterone Unshaved + Deodorant Antiperspirant Stick', 'description': 'Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.'}, {'id': 'OG004', 'title': 'Testosterone Shaved', 'description': 'No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.'}, {'id': 'OG005', 'title': 'Testosterone Shaved + Deodorant Antiperspirant Spray', 'description': 'Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.'}], 'classes': [{'categories': [{'measurements': [{'value': '2120', 'spread': '164.0', 'groupId': 'OG000'}, {'value': '2400', 'spread': '196.0', 'groupId': 'OG001'}, {'value': '2970', 'spread': '92.0', 'groupId': 'OG002'}, {'value': '2880', 'spread': '129.0', 'groupId': 'OG003'}, {'value': '3110', 'spread': '129.0', 'groupId': 'OG004'}, {'value': '2070', 'spread': '1733.0', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug', 'description': 'The AUC from time 0 to 72 hours \\[AUC (0-72)\\] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.', 'unitOfMeasure': 'nanograms* hours per deciliter (ng*h/dL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Testosterone Unshaved', 'description': 'No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.'}, {'id': 'OG001', 'title': 'Testosterone Unshaved + Deodorant Spray', 'description': 'Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.'}, {'id': 'OG002', 'title': 'Testosterone Unshaved + Deodorant Antiperspirant Spray', 'description': 'Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution .'}, {'id': 'OG003', 'title': 'Testosterone Unshaved + Deodorant Antiperspirant Stick', 'description': 'Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.'}, {'id': 'OG004', 'title': 'Testosterone Shaved', 'description': 'No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.'}, {'id': 'OG005', 'title': 'Testosterone Shaved + Deodorant Antiperspirant Spray', 'description': 'Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.'}], 'classes': [{'categories': [{'measurements': [{'value': '214', 'spread': '97.0', 'groupId': 'OG000'}, {'value': '209', 'spread': '119.0', 'groupId': 'OG001'}, {'value': '234', 'spread': '106.0', 'groupId': 'OG002'}, {'value': '202', 'spread': '97.0', 'groupId': 'OG003'}, {'value': '231', 'spread': '102.0', 'groupId': 'OG004'}, {'value': '151', 'spread': '519.0', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug', 'description': 'The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.', 'unitOfMeasure': 'nanograms per deciliter (ng/dL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1', 'description': '30-milligram (mg) testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.'}, {'id': 'FG001', 'title': 'Sequence 2', 'description': '30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.'}, {'id': 'FG002', 'title': 'Sequence 3', 'description': '30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.'}, {'id': 'FG003', 'title': 'Sequence 4', 'description': '30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout From Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'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': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout From Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout From Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout From Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Washout From Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Period 6', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'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': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Testosterone 2% Solution', 'description': 'Participants randomized to 1 of 4 treatment sequences involving 6 treatments in each sequence. Each sequence involved 4 single-dose treatments of testosterone 2% solution to unshaved axillae with or without the use of deodorant or antiperspirant products followed by 2 single-dose treatments of testosterone 2% solution to shaved axillae with or without the use of deodorant or antiperspirant products. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'spread': '7.9', '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': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native/White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Screening Testosterone', 'classes': [{'categories': [{'measurements': [{'value': '290.8', 'spread': '78.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nanograms per deciliter (ng/dL)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who received at least 1 dose of testosterone 2% solution.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-07', 'studyFirstSubmitDate': '2012-11-08', 'resultsFirstSubmitDate': '2014-01-17', 'studyFirstSubmitQcDate': '2012-11-08', 'lastUpdatePostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-17', 'studyFirstPostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone', 'timeFrame': 'Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug', 'description': 'The AUC from time 0 to 72 hours \\[AUC (0-72)\\] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.'}, {'measure': 'Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone', 'timeFrame': 'Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug', 'description': 'The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'referencesModule': {'references': [{'pmid': '25123988', 'type': 'DERIVED', 'citation': "Small DS, Ni X, Polzer P, Vart R, Satonin DK, Mitchell MI. Effect of deodorant and antiperspirant use and presence or absence of axillary hair on absorption of testosterone 2% solution applied to men's axillae. J Sex Med. 2014 Nov;11(11):2809-17. doi: 10.1111/jsm.12658. Epub 2014 Aug 14."}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of deodorant and antiperspirant use and the presence of underarm hair on the absorption of testosterone. Each participant in this study will receive 6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm. There is a minimum one day washout period between each dose. This study will last approximately 24 days not including screening. Screening is required within 30 days prior to the start of the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy males, as determined by medical history and physical examination\n* Agree to use a reliable method of birth control (for example, condom or vasectomy) during the study and for 1 month following the last dose of testosterone\n* Have a total testosterone level \\<400 nanograms per deciliter (ng/dL) based on local laboratory result\n* Have a hemoglobin ≥12 grams per deciliter (g/dL) at screening and, if the participant takes a break from the study, at the re-test\n* Weigh at least 60 kilograms (kg)\n* Have venous access sufficient to allow for blood sampling\n* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n* Have given written informed consent approved by Eli Lilly and Company (Lilly) and the ethical review board (ERB) governing the site\n\nExclusion Criteria:\n\n* Use any topical testosterone replacement therapy within the 2 weeks prior to randomization through the last dosing period, except for use of testosterone solution as directed by study procedures\n* Use parenteral testosterone replacement (testosterone enanthanate, testosterone cypionate) within the 30 days prior to screening. Use long-acting intramuscular testosterone undecanoate 6 months prior to screening, or use of testosterone pellets 12 months prior to screening\n* Have a body mass index \\>35 kilograms per square meter (kg/m\\^2)\n* Have a significant history of allergy and/or sensitivity to the drug products or excipients, including any history of sensitivity to testosterone\n* Currently use any medications, herbal, and/or nutritional supplements that can interfere with testosterone\n* Have a dermatologic condition in the underarm area that might interfere with testosterone absorption (for example, eczema) or be exacerbated by topical testosterone replacement therapy\n* Have a history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, endocrine, hematological, or neurological disorders constituting a risk when taking the study medication of that could interfere with the interpretation of the data\n* Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years\n* Have an abnormal prostate-specific antigen (PSA) test result\n* Have known allergies to testosterone solution, related compounds or any components of the formulation, or history of significant atopy\n* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study\n* Have an abnormal blood pressure as determined by the investigator\n* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening\n* Show evidence of hepatitis B and/or positive hepatitis B surface antigen\n* Show evidence of hepatitis C and/or positive hepatitis C antibody\n* Show evidence of human immunodeficiency (HIV) infection and/or positive human HIV antibodies\n* Are participants who have previously completed or withdrawn from this study or any other study investigating testosterone\n* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study\n* In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study\n* Have shaved the axillae within 3 months of screening'}, 'identificationModule': {'nctId': 'NCT01725451', 'briefTitle': 'A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Effects of Deodorant and Antiperspirant Use and the Presence of Axillary Hair on the Absorption of Testosterone Applied as Testosterone 2% Solution', 'orgStudyIdInfo': {'id': '15083'}, 'secondaryIdInfos': [{'id': 'I5E-MC-TSBD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Testosterone Unshaved', 'description': 'No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each unshaved axilla in 1 of 6 treatment periods.', 'interventionNames': ['Drug: Testosterone']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone Unshaved + Deodorant Spray', 'description': 'Deodorant spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.', 'interventionNames': ['Drug: Testosterone', 'Other: Deodorant Spray']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone Unshaved + Deodorant Antiperspirant Spray', 'description': 'Deodorant antiperspirant combination spray applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.', 'interventionNames': ['Drug: Testosterone', 'Other: Deodorant and Antiperspirant Combination Spray']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone Unshaved + Deodorant Antiperspirant Stick', 'description': 'Deodorant antiperspirant combination stick applied to unshaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.', 'interventionNames': ['Drug: Testosterone', 'Other: Deodorant and Antiperspirant Combination Stick']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone Shaved', 'description': 'No deodorant or antiperspirant: Single 30 mg dose of testosterone applied topically to each shaved axilla in 1 of 6 treatment periods.', 'interventionNames': ['Drug: Testosterone']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone Shaved + Deodorant Antiperspirant Spray', 'description': 'Deodorant antiperspirant combination spray applied to shaved axillae. At least 2 minutes wait time. Then, single 30 mg dose of testosterone applied topically to each axilla in 1 of 6 treatment periods.', 'interventionNames': ['Drug: Testosterone', 'Other: Deodorant and Antiperspirant Combination Spray']}], 'interventions': [{'name': 'Testosterone', 'type': 'DRUG', 'otherNames': ['Axiron', 'LY900011'], 'description': 'Administered topically to axillae', 'armGroupLabels': ['Testosterone Shaved', 'Testosterone Shaved + Deodorant Antiperspirant Spray', 'Testosterone Unshaved', 'Testosterone Unshaved + Deodorant Antiperspirant Spray', 'Testosterone Unshaved + Deodorant Antiperspirant Stick', 'Testosterone Unshaved + Deodorant Spray']}, {'name': 'Deodorant Spray', 'type': 'OTHER', 'description': 'Administered topically to axillae', 'armGroupLabels': ['Testosterone Unshaved + Deodorant Spray']}, {'name': 'Deodorant and Antiperspirant Combination Spray', 'type': 'OTHER', 'description': 'Administered topically to axillae', 'armGroupLabels': ['Testosterone Shaved + Deodorant Antiperspirant Spray', 'Testosterone Unshaved + Deodorant Antiperspirant Spray']}, {'name': 'Deodorant and Antiperspirant Combination Stick', 'type': 'OTHER', 'description': 'Administered topically to axillae', 'armGroupLabels': ['Testosterone Unshaved + Deodorant Antiperspirant Stick']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', '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': 29.21081, 'lon': -81.02283}}, {'zip': '47710', 'city': 'Evansville', 'state': 'Indiana', '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': 37.97476, 'lon': -87.55585}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 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': {'type': 'SPONSOR'}}}}