Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT00924612
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2009-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005058', 'term': 'Eunuchism'}, {'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010792', 'term': 'testosterone undecanoate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rdudley@clarustherapeutics.com', 'phone': '847-562-4300', 'title': 'Robert E. Dudley, PhD, CEO and President', 'organization': 'Clarus Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'Throughout the study, subjects were monitored for AEs. At the beginning of each study period, after the subject had had an opportunity to spontaneously mention any problems, the Principal Investigator, or nominee, inquired about AEs by asking standard questions.', 'eventGroups': [{'id': 'EG000', 'title': 'Fasting', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state\n\nOral testosterone undecanoate (containing 300 mg T)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Very Low Fat Diet', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with very low fat (6-10% fat).\n\nOral testosterone undecanoate (containing 300 mg T)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Low Fat Diet', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with low fat (20% fat).\n\nOral testosterone undecanoate (containing 300 mg T)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Normal Diet', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with normal fat (30% fat).\n\nOral testosterone undecanoate (containing 300 mg T)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'High Fat Diet', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with high fat (50% fat).\n\nOral testosterone undecanoate (containing 300 mg T)', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Catheter site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otopharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Fasting', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state\n\nOral testosterone undecanoate (containing 300 mg T)'}, {'id': 'OG001', 'title': 'Very Low Fat Diet', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with very low fat (6-10% fat).\n\nOral testosterone undecanoate (containing 300 mg T)'}, {'id': 'OG002', 'title': 'Low Fat Diet', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with low fat (20% fat).\n\nOral testosterone undecanoate (containing 300 mg T)'}, {'id': 'OG003', 'title': 'Normal Diet', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with normal fat (30% fat).\n\nOral testosterone undecanoate (containing 300 mg T)'}, {'id': 'OG004', 'title': 'High Fat Diet', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with high fat (50% fat).\n\nOral testosterone undecanoate (containing 300 mg T)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.38', 'spread': '0.456', 'groupId': 'OG000'}, {'value': '6.73', 'spread': '0.410', 'groupId': 'OG001'}, {'value': '6.88', 'spread': '0.356', 'groupId': 'OG002'}, {'value': '7.00', 'spread': '0.264', 'groupId': 'OG003'}, {'value': '7.18', 'spread': '0.312', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '130.83', 'ciLowerLimit': '113.59', 'ciUpperLimit': '150.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0844', 'groupDescription': 'Comparison of diets based on full crossover model', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'ANOVA of a multicenter, 4 sequence, 5 treatment crossover model using ln-transformed data. Normal fat diet compared to fasting, very low fat, low fat, and high fat diets as part of the overall analysis. No adjustments for multiplicity made.'}, {'pValue': '0.8494', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.84', 'ciLowerLimit': '86.80', 'ciUpperLimit': '119.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0954', 'groupDescription': 'Comparison of diets based on full crossover model', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0013', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '73.55', 'ciLowerLimit': '63.23', 'ciUpperLimit': '85.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0902', 'groupDescription': 'Comparison of diets based on full crossover model', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '62.62', 'ciLowerLimit': '53.38', 'ciUpperLimit': '76.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0954', 'groupDescription': 'Comparison of diets based on full crossover model', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '25 hour serial blood draws separated by 4 to 10 days of washout between treatments.', 'description': 'PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence ABCDE', 'description': 'Fasting (Treatment A) followed by dose-associated breakfast meals comprised of \\~ 800 calories consisting of very low fat (6-10% fat; Treatment B), low fat (20% fat; Treatment C), "normal diet" (30% fat; Treatment D), and high fat (50% fat; Treatment E).\n\nParticipants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days.'}, {'id': 'FG001', 'title': 'Sequence BDCEA', 'description': 'Dose-associated breakfast meals comprised of \\~ 800 calories consisting of very low fat (6-10% fat; Treatment B), followed by "normal diet" (30% fat; Treatment D), low fat (20% fat; Treatment C), high fat (50% fat; Treatment E) and fasting (Treatment A).\n\nParticipants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days.'}, {'id': 'FG002', 'title': 'Sequence CBEDA', 'description': 'Dose-associated breakfast meals comprised of \\~ 800 calories consisting of low fat (20% fat; Treatment C), followed by very low fat (6-10% fat; Treatment B), high fat (50% fat; Treatment E) "normal diet" (30% fat; Treatment D), and fasting (Treatment A).\n\nParticipants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days.'}, {'id': 'FG003', 'title': 'Sequence DBAEC', 'description': 'Dose-associated breakfast meals comprised of \\~ 800 calories consisting of "normal diet" (30% fat; Treatment D), followed by very low fat (6-10% fat; Treatment B), fasting (Treatment A), high fat (50% fat; Treatment E) and low fat (20% fat; Treatment C), Participants received a single dose of oral testosterone undecanoate (containing 300 mg T) administered in the fasted state and at 30 minutes after the initiation of protocol-defined breakfasts. Treatments were separated by 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Sixteen subjects (8 at each study center) were enrolled. A total of 72 subjects were screened (16 subjects at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and 56 subjects were screened at Anapharm, beginning on April 3, 2009.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state (Treatment A) and followed by a dose-associated breakfast meal comprised of \\~800 calories consisting of very low fat (6-10% fat, Treatment B), low fat (20% fat, Treatment C), normal diet (30% fat, Treatment D) and high fat (50% fat, Treatment E). Participants were randomized to one of the 4 treatment sequences (ABCDE, BDCEA, CBEDA, OR DBAEC).\n\nOral testosterone undecanoate (containing 300 mg T)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'spread': '14', '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': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', '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': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '174.1', 'spread': '7.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '91.1', 'spread': '14.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'spread': '4.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Cross over design in which each enrolled subject participated in each arm in a randomized order.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Open-label, five-period, randomized, four-sequence (ABCDE, BDCEA,CBEDA, DBAEC), cross-over study to determine the effect of food containing various amounts of dietary fat on the pharmacokinetics of oral TU.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'dispFirstSubmitDate': '2010-08-17', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2009-06-17', 'dispFirstSubmitQcDate': '2010-08-17', 'resultsFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2009-06-18', 'dispFirstPostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-06', 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet', 'timeFrame': '25 hour serial blood draws separated by 4 to 10 days of washout between treatments.', 'description': 'PK population where subjects are randomly assigned to one of four dietary sequences of five fat regimens. Active drug is identical for all subjects and all diets. Effect of normal dietary fat is compared to fasting, very low fat, low fat, and high fat diets for mean T Cavg25.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary hypogonadism', 'Secondary hypogonadism'], 'conditions': ['Male Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.', 'detailedDescription': 'Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age 18-65\n* Morning serum testosterone (T) \\<300 ng/dL on two occasions\n\nExclusion Criteria:\n\n* Significant intercurrent disease\n* Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score \\>15 or history of prostate cancer.\n* Serum transaminases \\>2 times upper limit of normal\n* Serum bilirubin \\>2.0 mg/dL\n* Hematocrit \\<35% or \\>50%\n* BMI \\>36\n* Untreated, obstructive sleep apnea.'}, 'identificationModule': {'nctId': 'NCT00924612', 'briefTitle': 'Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clarus Therapeutics, Inc.'}, 'officialTitle': 'Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men', 'orgStudyIdInfo': {'id': 'CLAR-09008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasting (Treatment A)', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered orally in a fasted state', 'interventionNames': ['Drug: Oral testosterone undecanoate (containing 300 mg T)']}, {'type': 'EXPERIMENTAL', 'label': 'Very low fat diet (Treatment B)', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with very low fat (6-10% fat).', 'interventionNames': ['Drug: Oral testosterone undecanoate (containing 300 mg T)']}, {'type': 'EXPERIMENTAL', 'label': 'Low fat diet (Treatment C)', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with low fat (20% fat).', 'interventionNames': ['Drug: Oral testosterone undecanoate (containing 300 mg T)']}, {'type': 'EXPERIMENTAL', 'label': 'Normal diet (Treatment D)', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with normal fat (30% fat).', 'interventionNames': ['Drug: Oral testosterone undecanoate (containing 300 mg T)']}, {'type': 'EXPERIMENTAL', 'label': 'High fat diet (Treatment E)', 'description': 'Single dose of oral testosterone undecanoate (containing 300 mg T) administered, 30 minutes after the initiation of protocol-defined breakfast of \\~800 calories with high fat (50% fat).', 'interventionNames': ['Drug: Oral testosterone undecanoate (containing 300 mg T)']}], 'interventions': [{'name': 'Oral testosterone undecanoate (containing 300 mg T)', 'type': 'DRUG', 'armGroupLabels': ['Fasting (Treatment A)', 'High fat diet (Treatment E)', 'Low fat diet (Treatment C)', 'Normal diet (Treatment D)', 'Very low fat diet (Treatment B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'LABiomedical Research Institute at Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': 'G1P 0A2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Anapharm, Inc.', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Ronald Swerdloff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LABiomedical Research Institute at Harbor-UCLA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clarus Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}