This project will evaluate the effect of estrogen treatment on how other medications are processed by the body.
Estradiol is prepared as a medication that patients may take to increase hormone levels. Changes in estradiol concentrations in the body may affect how the body processes other medicines. The purpose of this study is to find out how estradiol therapy affects a single tracer dose of approved medicines in the blood (midazolam, digoxin, and acetaminophen) and to confirm estradiol treatment does not affect natural bacterial in the gut.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
22
2 mg single-dose before and during estradiol treatment.
0.25 mg single-dose before and during estradiol treatment.
500 mg single-dose before and during estradiol treatment.
University of Washington
Seattle, Washington, United States
midazolam AUC ratio (treatment/control)
ratio of the area under of the plasma concentration time curve (AUC) of midazolam in the presence to absence of gender-affirming estradiol treatment.
Time frame: 0-6 hours
digoxin renal clearance (treatment/control)
ratio of digoxin renal clearance in the presence to absence of gender-affirming estradiol treatment.
Time frame: 0-48
midazolam Cmax ratio (treatment/control)
ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming estradiol treatment
Time frame: 0-6 hours
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1 mg intravenous single-dose before and during estradiol treatment.