Effect of Testosterone Treatment on Drug Metabolism and Transport

Transgender Persons Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05116293
• Other study ID #: STUDY00011644
• Status: Active, not recruiting
• Start date: May 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Gender-affirming hormone therapy may include testosterone, a hormone that the body creates and uses naturally. Testosterone is prepared as a medication that patients may take to increase hormone levels. Changes in testosterone concentrations in the body may affect how the body processes other medicines. The purpose of this study is to find out how testosterone therapy affects a single tracer dose of approved medicines in the blood (midazolam, digoxin, and acetaminophen) and to confirm testosterone treatment does not affect natural bacterial in the gut.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 31, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Self-identified trans* adult at least 18 years of age.
• Not taking testosterone treatment currently.
• Planning to start testosterone treatment through care provider 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
Oral syrup
• Digoxin Oral Tablet
Oral tablet
• Acetaminophen Oral Tablet
Oral tablet

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

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 testosterone treatment.	0-48 hours
Secondary	midazolam Cmax ratio (treatment/control)	ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming testosterone treatment	0-48 hours