Effect of Estrogen Treatment on Drug Metabolism and Transport

Transgender Persons Clinical Trial

Official title:

Effect of Gender-Affirming Estrogen Therapy on Drug Metabolism, Transport, and Gut Microbiota

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05469204
• Other study ID #: STUDY00014091
• Secondary ID: 1K23GM147350
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: Lauren Cirrincione (she/her), PharmD, MPH
• Phone: 650-353-7782
• Email: lc10[@]uw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Transgender Persons

Intervention

Drug:
• Midazolam oral solution
2 mg single-dose before and during estradiol treatment.
• Digoxin Oral Tablet
0.25 mg single-dose before and during estradiol treatment.
• Acetaminophen Oral Tablet
500 mg single-dose before and during estradiol treatment.
• Midazolam Injectable Solution
1 mg intravenous single-dose before and during estradiol treatment.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-6 hours
Primary	digoxin renal clearance (treatment/control)	ratio of digoxin renal clearance in the presence to absence of gender-affirming estradiol treatment.	0-48
Secondary	midazolam Cmax ratio (treatment/control)	ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming estradiol treatment	0-6 hours