NCT05469204

Brief Summary

This project will evaluate the effect of estrogen 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
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2022

Typical duration for phase_4

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

First Submitted

Initial submission to the registry

July 19, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

July 19, 2022

Last Update Submit

January 7, 2026

Conditions

Transgender Persons

Keywords

hormone therapyestrogen treatment

Outcome Measures

Primary Outcomes (2)

  • 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

  • digoxin renal clearance (treatment/control)

    ratio of digoxin renal clearance in the presence to absence of gender-affirming estradiol treatment.

    0-48

Secondary Outcomes (1)

  • midazolam Cmax ratio (treatment/control)

    0-6 hours

Study Arms (1)

Healthy transgender adults

OTHER

Healthy transgender adults will be studied on two separate study days and serve as their own control.

Drug: Midazolam oral solutionDrug: Digoxin Oral TabletDrug: Acetaminophen Oral TabletDrug: Midazolam Injectable Solution

Interventions

Midazolam oral solutionDRUG

2 mg single-dose before and during estradiol treatment.

Healthy transgender adults
Digoxin Oral TabletDRUG

0.25 mg single-dose before and during estradiol treatment.

Healthy transgender adults
Acetaminophen Oral TabletDRUG

500 mg single-dose before and during estradiol treatment.

Healthy transgender adults
Midazolam Injectable SolutionDRUG

1 mg intravenous single-dose before and during estradiol treatment.

Healthy transgender adults

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-identify as transgender or trans nonbinary
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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 Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 19, 2022

First Posted

July 21, 2022

Study Start

November 1, 2022

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

US(1)