Effect of Testosterone Treatment on Drug Metabolism and Transport
- Conditions
- Transgender Persons
- Registration Number
- NCT05116293
- Lead Sponsor
- University of Washington
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
- 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.
- Unwilling/unable to return for project follow-up visits.
- Unwilling/unable to provide written informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
University of Washington
🇺🇸Seattle, Washington, United States