Effect of Gender-Affirming Testosterone Therapy on Drug Metabolism, Transport, and Gut Microbiota
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- midazolam AUC ratio (treatment/control)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
midazolam AUC ratio (treatment/control)
Time Frame: 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 Outcomes
- midazolam Cmax ratio (treatment/control)(0-48 hours)
Investigators
Lauren Cirrincione
Assistant Professor, Pharmacy
University of Washington