Effect of Testosterone Treatment on Drug Metabolism and Transport

• Sponsor: University of Washington (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05116293
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

This project will evaluate the effect of gender-affirming testosterone treatment on how other medications are processed by the body.

Condition or Disease	Intervention/Treatment	Phase
Transgender Persons	Drug: Midazolam oral solution; Drug: Digoxin Oral Tablet; Drug: Acetaminophen Oral Tablet

Detailed Description

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 14 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Gender-Affirming Testosterone Therapy on Drug Metabolism, Transport, and Gut Microbiota
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Outcome Measures

Primary Outcome Measures

1. midazolam AUC ratio (treatment/control) [0-48 hours]

   ratio of the area under of the plasma concentration time curve (AUC) of midazolam in the presence to absence of gender-affirming testosterone treatment.

Secondary Outcome Measures

1. midazolam Cmax ratio (treatment/control) [0-48 hours]

   ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming testosterone treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Self-identified trans* adult at least 18 years of age.

• Not taking testosterone treatment currently.

• Planning to start testosterone treatment through care provider for gender-affirming medical care.

Exclusion Criteria:

• Unwilling/unable to return for project follow-up visits.

• Unwilling/unable to provide written informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

• University of Washington

Investigators

• Principal Investigator: Lauren Cirrincione, MPH,Pharm D, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lauren Cirrincione, Assistant Professor, Pharmacy, University of Washington
• ClinicalTrials.gov Identifier: NCT05116293
• Other Study ID Numbers: STUDY00011644
• First Posted: Nov 11, 2021
• Last Update Posted: Nov 11, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lauren Cirrincione, Assistant Professor, Pharmacy, University of Washington: Testosterone Treatment
• Additional relevant MeSH terms: Acetaminophen; Digoxin; Midazolam

Study Results

No Results Posted as of Nov 11, 2021