Effect of Estrogen Treatment on Drug Metabolism and Transport

University of Washington

Status and phase: Completed; Phase 4

Conditions: Transgender Persons

Treatments: Drug: Digoxin Oral Tablet; Drug: Midazolam oral solution; Drug: Midazolam Injectable Solution; Drug: Acetaminophen Oral Tablet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05469204

1K23GM147350 (U.S. NIH Grant/Contract)

STUDY00014091

Details and patient eligibility

About

This project will evaluate the effect of estrogen treatment on how other medications are processed by the body.

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Self-identified trans* adult 18-55 years of age.
• Not taking estradiol treatment currently.
• Planning to start injectable estradiol or estradiol tablets for gender-affirming medical care.

Exclusion criteria

• Unwilling/unable to return for project follow-up visits.
• Unwilling/unable to provide written informed consent.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Healthy transgender adults

Other group

Description:

Healthy transgender adults will be studied on two separate study days and serve as their own control.

Treatment:

Drug: Acetaminophen Oral Tablet

Drug: Midazolam Injectable Solution

Drug: Midazolam oral solution

Drug: Digoxin Oral Tablet