NCT05116293

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

October 15, 2021

Last Update Submit

April 27, 2026

Conditions

Transgender Persons

Keywords

Testosterone Treatment

Outcome Measures

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.

    0-48 hours

Secondary Outcomes (1)

  • midazolam Cmax ratio (treatment/control)

    0-48 hours

Interventions

Midazolam oral solutionDRUG

Oral syrup

Digoxin Oral TabletDRUG

Oral tablet

Acetaminophen Oral TabletDRUG

Oral tablet

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-identify as transgender or trans nonbinary
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Transgender adults planning to take testosterone treatment.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Interventions

MidazolamDigoxinAcetaminophen

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDigitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydratesAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Lauren Cirrincione, MPH,Pharm D

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Pharmacy

Study Record Dates

First Submitted

October 15, 2021

First Posted

November 11, 2021

Study Start

May 1, 2021

Primary Completion

February 15, 2024

Study Completion

December 31, 2025

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

US(1)