Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-30 @ 7:10 PM
Study NCT ID:
NCT05116293
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-13
First Post:
2021-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Testosterone Treatment on Drug Metabolism and Transport
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D004077', 'term': 'Digoxin'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2021-10-15', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'midazolam AUC ratio (treatment/control)', 'timeFrame': '0-48 hours', 'description': 'ratio of the area under of the plasma concentration time curve (AUC) of midazolam in the presence to absence of gender-affirming testosterone treatment.'}], 'secondaryOutcomes': [{'measure': 'midazolam Cmax ratio (treatment/control)', 'timeFrame': '0-48 hours', 'description': 'ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming testosterone treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Testosterone Treatment'], 'conditions': ['Transgender Persons']}, 'descriptionModule': {'briefSummary': 'This project will evaluate the effect of gender-affirming testosterone treatment on how other medications are processed by the body.', 'detailedDescription': 'Gender-affirming hormone therapy may include testosterone, a hormone that the body creates and uses naturally. Testosterone is prepared as a medication that patients may take to increase hormone levels. Changes in testosterone concentrations in the body may affect how the body processes other medicines. The purpose of this study is to find out how testosterone therapy affects a single tracer dose of approved medicines in the blood (midazolam, digoxin, and acetaminophen) and to confirm testosterone treatment does not affect natural bacterial in the gut.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Transgender adults planning to take testosterone treatment.', 'genderDescription': 'Self-identify as transgender or trans nonbinary', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identified trans\\* adult at least 18 years of age.\n* Not taking testosterone treatment currently.\n* Planning to start testosterone treatment through care provider for gender-affirming medical care.\n\nExclusion Criteria:\n\n* Unwilling/unable to return for project follow-up visits.\n* Unwilling/unable to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT05116293', 'briefTitle': 'Effect of Testosterone Treatment on Drug Metabolism and Transport', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Effect of Gender-Affirming Testosterone Therapy on Drug Metabolism, Transport, and Gut Microbiota', 'orgStudyIdInfo': {'id': 'STUDY00011644'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Midazolam oral solution', 'type': 'DRUG', 'description': 'Oral syrup'}, {'name': 'Digoxin Oral Tablet', 'type': 'DRUG', 'description': 'Oral tablet'}, {'name': 'Acetaminophen Oral Tablet', 'type': 'DRUG', 'description': 'Oral tablet'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Lauren Cirrincione, MPH,Pharm D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Pharmacy', 'investigatorFullName': 'Lauren Cirrincione', 'investigatorAffiliation': 'University of Washington'}}}}