Effect of Estrogen Treatment on Drug Metabolism and Transport

Phase 4

Recruiting

• Conditions: Transgender Persons
• Interventions: Drug: Midazolam oral solution; Drug: Digoxin Oral Tablet; Drug: Acetaminophen Oral Tablet; Drug: Midazolam Injectable Solution

• Registration Number: NCT05469204
• Lead Sponsor: University of Washington

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-21
• Study Start: 2022-11-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 13

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy transgender adults	Acetaminophen Oral Tablet	Healthy transgender adults will be studied on two separate study days and serve as their own control.
Healthy transgender adults	Midazolam Injectable Solution	Healthy transgender adults will be studied on two separate study days and serve as their own control.
Healthy transgender adults	Midazolam oral solution	Healthy transgender adults will be studied on two separate study days and serve as their own control.
Healthy transgender adults	Digoxin Oral Tablet	Healthy transgender adults will be studied on two separate study days and serve as their own control.

Primary Outcome Measures

Name	Time	Method
midazolam AUC ratio (treatment/control)	0-6 hours	ratio of the area under of the plasma concentration time curve (AUC) of midazolam in the presence to absence of gender-affirming estradiol treatment.
digoxin renal clearance (treatment/control)	0-48	ratio of digoxin renal clearance in the presence to absence of gender-affirming estradiol treatment.

Secondary Outcome Measures

Name	Time	Method
midazolam Cmax ratio (treatment/control)	0-6 hours	ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming estradiol treatment

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States