NCT05116293

Effect of Testosterone Treatment on Drug Metabolism and Transport

Effect of Gender-Affirming Testosterone Therapy on Drug Metabolism, Transport, and Gut Microbiota

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Transgender Persons

Interventions

Type	Name	Description
DRUG	Midazolam oral solution	Oral syrup
DRUG	Digoxin Oral Tablet	Oral tablet
DRUG	Acetaminophen Oral Tablet	Oral tablet

Timeline

• Start date: 2021-05-01
• Primary completion: 2024-02-15
• Completion: 2025-12-31
• First posted: 2021-11-11
• Last updated: 2025-06-13

Locations

1 site across 1 country: United States