Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT06393634
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2024-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D043343', 'term': 'Testosterone Propionate'}, {'id': 'C010792', 'term': 'testosterone undecanoate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three groups in phase one and two groups in phase two, randomized by a computer.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection windows of testosterone administered via injection, oral and skin cream.', 'timeFrame': '12 weeks', 'description': 'Changes in urinary testosterone/epitestosterone ratio after administration of testosterone in injection, oral and cream'}, {'measure': 'Changes in serum concentration of testosterone', 'timeFrame': '12 weeks', 'description': 'Changes in serum concentrations of testosterone in injection, oral and cream administration of testosterone'}, {'measure': 'Changes in serum concentration of androstenedione', 'timeFrame': '12 weeks', 'description': 'Changes in serum concentrations of androstenedione in injection, oral and cream administration of testosterone'}, {'measure': 'Changes in serum concentration of luteinizing hormone', 'timeFrame': '12 weeks', 'description': 'Changes in serum concentrations of luteinizing hormone after injection, oral and cream administration of testosterone'}], 'secondaryOutcomes': [{'measure': 'Direct detection of testosterone esters', 'timeFrame': '12 weeks', 'description': 'Direct detection of testosterone esters'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Testosterone abuse is extremely prevalent in athletes globally and especially in the United States professional sporting leagues', 'detailedDescription': 'Because human bodies make testosterone naturally, it can be difficult to determine whether the testosterone in your body is natural or if it came from administering testosterone. Currently, testosterone abuse by athletes is detected by anti-doping laboratories in urine samples and use can also be inferred by testing blood samples. As a pharmaceutical preparation, testosterone is available to administer to your body in different ways. However, due to lack of controlled data on the various preparations of testosterone administrations related to the anti-doping field, this study id designed to look at five different testosterone preparations delivered three different ways and how they compare to each other in terms of anti-doping detection and how long they will be in circulation in your body.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HEALTHY MALE ADULTS, AGED 18-60 YEARS\n\nExclusion Criteria:\n\n* Individuals currently enrolled in a registered testing pool for anti-doping purposes\n* Unwilling to provide urine or blood samples\n* Individuals who are not actively exercising\n* Individuals who show a high risk of heart attack or cardiovascular disease as defined by a physician\n* Individuals that have an elevated baseline hematocrit as determined by the PI\n* Individuals who are diabetic or are currently taking diabetic medications.\n* Individuals that have donated blood (approximately 500 mL) in the past 8 weeks\n* Individuals with severe acne\n* Individuals with a history of cancer, cardiac, renal or hepatic disease'}, 'identificationModule': {'nctId': 'NCT06393634', 'acronym': 'T esters', 'briefTitle': 'Comparing Direct and Indirect Detection Methods of Multiple Routes of Testosterone Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sports Medicine Research and Testing Laboratory'}, 'officialTitle': 'Comparing Direct and Indirect Detection Methods Following Multiple Routes of Testosterone administration-an Anti-doping Perspective', 'orgStudyIdInfo': {'id': 'SMRTL.2024.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Testosterone group one', 'description': 'The participant will receive a single injection of one of three types of testosterone in phase one.\n\nIn phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow.', 'interventionNames': ['Drug: Testosterone injection', 'Drug: Testosterone gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Testosterone group two', 'description': 'The participant will receive a single injection of one of three types of testosterone in phase one.\n\nIn phase two the participant will receive two weeks of either a daily skin cream or a twice-daily pill to swallow.', 'interventionNames': ['Drug: Testosterone injection', 'Drug: Testosterone Oral']}], 'interventions': [{'name': 'Testosterone injection', 'type': 'DRUG', 'otherNames': ['testosterone cipionate, enanthate,or propionate'], 'description': 'A single injection of testosterone', 'armGroupLabels': ['Testosterone group one', 'Testosterone group two']}, {'name': 'Testosterone gel', 'type': 'DRUG', 'otherNames': ['testosterone transdermal'], 'description': 'A daily dose of testosterone gel', 'armGroupLabels': ['Testosterone group one']}, {'name': 'Testosterone Oral', 'type': 'DRUG', 'otherNames': ['testosterone undecanoate'], 'description': 'A twice-daily pill of testosterone pill to swallow', 'armGroupLabels': ['Testosterone group two']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Sports Medicine Research and Testing Laboratory', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}], 'overallOfficials': [{'name': 'Geoff Miller, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sports Medicine Research and Testing Laboratory'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sports Medicine Research and Testing Laboratory', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}