CClinicalTrials.gg
CompletedNCT05116293Updated May 4, 2026

Effect of Testosterone Treatment on Drug Metabolism and Transport

An observational study in Transgender Persons, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Washington · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
14
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Transgender Persons

Keywords

  • Testosterone Treatment
03

In context

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Transgender adults planning to take testosterone treatment.

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

Exclusion Criteria:

  • Unwilling/unable to return for project follow-up visits.
  • Unwilling/unable to provide written informed consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No

Interventions

  • DrugMidazolam oral solution

    Oral syrup

  • DrugDigoxin Oral Tablet

    Oral tablet

  • DrugAcetaminophen Oral Tablet

    Oral tablet

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-48 hours

Secondary outcomes

  1. midazolam Cmax ratio (treatment/control)

    ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming testosterone treatment

    Time frame: 0-48 hours

07

Study locations

1 site
  • University of Washington
    Seattle, Washington 98195, United States
08

References and documents

Publications

  • Hunter M, Coig R, Risler L, Patton KK, Narla RR, Greene DN, Burke AK, Micks E, Hebert MF, Cirrincione LR. Effect of Testosterone Therapy on Cytochrome P450 3A and P-Glycoprotein Activities Using Midazolam and Digoxin as Probe Substrates Among Transgender Adults. Pharmacotherapy. 2026 Feb;46(2):e70093. doi: 10.1002/phar.70093. Epub 2025 Dec 26. PubMed 41452771 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05116293
Lead sponsor
University of Washington
Responsible party
Lauren Cirrincione (Assistant Professor, Pharmacy, University of Washington) — Principal investigator
First posted
Nov 11, 2021
Start date
May 1, 2021
Primary completion
Feb 15, 2024
Completion
Dec 31, 2025
Last update
May 4, 2026

Study contacts

Lauren Cirrincione, MPH,Pharm D
principal investigator · University of Washington

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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