Transgender Persons
Conditions
Keywords
Testosterone Treatment
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.
Interventions
Oral syrup
Oral tablet
Oral tablet
Sponsors
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed