Effect of Testosterone Treatment on Drug Metabolism and Transport

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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

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Transgender Persons

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Midazolam oral solution

Oral syrup

Intervention Type DRUG

Digoxin Oral Tablet

Oral tablet

Intervention Type DRUG

Acetaminophen Oral Tablet

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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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.