Effect of Estrogen Treatment on Drug Metabolism and Transport

24 Jan Effect of Estrogen Treatment on Drug Metabolism and Transport

Gender-affirming hormone therapy may include estradiol, a hormone that the body creates and uses naturally. 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 Visits: Participants will be asked to attend four study visits (before and 12-weeks after starting
estrogen therapy):

1. Study Visit 1 will take place at the University of Washington Medical Center Translational
Research Unit for an overnight visit (approximately 24 hours). During that time, you will be
provided with a single dose of three approved medications by mouth (midazolam, digoxin,
acetaminophen) and by injection into your vein (midazolam). Your blood will be drawn 20 times
from a small tube placed in your arm. Your urine will also be collected. You will be asked by the
study coordinator to collect a stool sample before this visit and bring it with you. You will be asked
to collect your urine overnight and return the next morning to the School of Pharmacy for one 45-
minute follow-up visit. During this follow-up, your blood will be drawn one time and the study
coordinator will collect your overnight urine sample.

2. Study Visit 2 (between 10 to 22 weeks after starting estrogen therapy) will be similar to Study Visit 1.

Cost: There is no cost to participate in this study. Hormone therapy is not provided by the study.

Stipend: Participant compensation is available up to $1115

Participant Eligibility

Inclusion Criteria:
1) Self-identified trans* adult at least 18 years of age.
2) Not taking estrogen treatment currently.
3) Transgender adults planning to take oral or injectable estradiol treatment.

Exclusion Criteria:
1) Unwilling/unable to return for project follow-up visits.
2) Unwilling/unable to provide written informed consent.

Contact

Lauren Cirrincione
(650) 353-7782