Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 11:06 PM
Study NCT ID:
NCT05469204
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2022-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Estrogen 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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2022-07-19', 'studyFirstSubmitQcDate': '2022-07-19', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'midazolam AUC ratio (treatment/control)', 'timeFrame': '0-6 hours', 'description': 'ratio of the area under of the plasma concentration time curve (AUC) of midazolam in the presence to absence of gender-affirming estradiol treatment.'}, {'measure': 'digoxin renal clearance (treatment/control)', 'timeFrame': '0-48', 'description': 'ratio of digoxin renal clearance in the presence to absence of gender-affirming estradiol treatment.'}], 'secondaryOutcomes': [{'measure': 'midazolam Cmax ratio (treatment/control)', 'timeFrame': '0-6 hours', 'description': 'ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming estradiol treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hormone therapy', 'estrogen treatment'], 'conditions': ['Transgender Persons']}, 'descriptionModule': {'briefSummary': 'This project will evaluate the effect of estrogen treatment on how other medications are processed by the body.', 'detailedDescription': 'Estradiol is prepared as a medication that patients may take to increase hormone levels. Changes in estradiol concentrations in the body may affect how the body processes other medicines. The purpose of this study is to find out how estradiol therapy affects a single tracer dose of approved medicines in the blood (midazolam, digoxin, and acetaminophen) and to confirm estradiol treatment does not affect natural bacterial in the gut.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-identify as transgender or trans nonbinary', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identified trans\\* adult 18-55 years of age.\n* Not taking estradiol treatment currently.\n* Planning to start injectable estradiol or estradiol tablets 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': 'NCT05469204', 'briefTitle': 'Effect of Estrogen Treatment on Drug Metabolism and Transport', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Effect of Gender-Affirming Estrogen Therapy on Drug Metabolism, Transport, and Gut Microbiota', 'orgStudyIdInfo': {'id': 'STUDY00014091'}, 'secondaryIdInfos': [{'id': '1K23GM147350', 'link': 'https://reporter.nih.gov/quickSearch/1K23GM147350', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy transgender adults', 'description': 'Healthy transgender adults will be studied on two separate study days and serve as their own control.', 'interventionNames': ['Drug: Midazolam oral solution', 'Drug: Digoxin Oral Tablet', 'Drug: Acetaminophen Oral Tablet', 'Drug: Midazolam Injectable Solution']}], 'interventions': [{'name': 'Midazolam oral solution', 'type': 'DRUG', 'description': '2 mg single-dose before and during estradiol treatment.', 'armGroupLabels': ['Healthy transgender adults']}, {'name': 'Digoxin Oral Tablet', 'type': 'DRUG', 'description': '0.25 mg single-dose before and during estradiol treatment.', 'armGroupLabels': ['Healthy transgender adults']}, {'name': 'Acetaminophen Oral Tablet', 'type': 'DRUG', 'description': '500 mg single-dose before and during estradiol treatment.', 'armGroupLabels': ['Healthy transgender adults']}, {'name': 'Midazolam Injectable Solution', 'type': 'DRUG', 'description': '1 mg intravenous single-dose before and during estradiol treatment.', 'armGroupLabels': ['Healthy transgender adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lauren Cirrincione', 'investigatorAffiliation': 'University of Washington'}}}}