Effect of Testosterone Treatment on Drug Metabolism and Transport

University of Washington

Status: Active, not recruiting

Conditions: Transgender Persons

Treatments: Drug: Acetaminophen Oral Tablet; Drug: Digoxin Oral Tablet; Drug: Midazolam oral solution

Study type: Observational

Funder types: Other

Identifiers

NCT05116293

STUDY00011644

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.