Effect of Estrogen Treatment on Drug Metabolism and Transport

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transgender Estradiol Affirming Therapy

NCT05010707

Transgenderism

COMPLETED PHASE2

Effect of Transgender Therapy on Muscle, Fat and Tissue Receptors

NCT04551144

Gender Incongruence Transgenderism

TERMINATED

Pubertal Blockade and Estradiol Effects on Cardiometabolic Health for Transitioning Youth

NCT04596592

Transgenderism Gender Dysphoria Insulin Sensitivity

RECRUITING

Effects of Cross-sex Hormone Therapy on Eating Behavior, Metabolism, Energy Balance and Cardiovascular System

NCT04838249

Transsexualism Transgenderism Adiposity +3 more

RECRUITING

Effects of Gender-Affirming Hormone Therapy Among Transgender Women

NCT04128488

Transgender Women HIV/AIDS Cardiovascular Diseases +2 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transgender Persons

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy transgender adults

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

Group Type OTHER

Midazolam oral solution

Intervention Type DRUG

2 mg single-dose before and during estradiol treatment.

Digoxin Oral Tablet

Intervention Type DRUG

0.25 mg single-dose before and during estradiol treatment.

Acetaminophen Oral Tablet

Intervention Type DRUG

500 mg single-dose before and during estradiol treatment.

Midazolam Injectable Solution

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Midazolam oral solution

2 mg single-dose before and during estradiol treatment.

Intervention Type DRUG

Digoxin Oral Tablet

0.25 mg single-dose before and during estradiol treatment.

Intervention Type DRUG

Acetaminophen Oral Tablet

500 mg single-dose before and during estradiol treatment.

Intervention Type DRUG

Midazolam Injectable Solution

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.