Effect of Estrogen Treatment on Drug Metabolism and Transport

Sponsor

University of Washington (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05469204

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Transgender Persons	Drug: Midazolam oral solution Drug: Digoxin Oral Tablet Drug: Acetaminophen Oral Tablet

Detailed Description

Gender-affirming hormone therapy may include estradiol, a hormone that the body creates and uses naturally. 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

13 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

midazolam AUC ratio (treatment/control) [0-6 hours]
ratio of the area under of the plasma concentration time curve (AUC) of midazolam in the presence to absence of gender-affirming estradiol treatment.
digoxin renal clearance (treatment/control) [0-48]
ratio of digoxin renal clearance in the presence to absence of gender-affirming estradiol treatment.

Secondary Outcome Measures

midazolam Cmax ratio (treatment/control) [0-6 hours]
ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming estradiol treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Self-identified trans* adult 18-45 years of age.
Not taking estradiol treatment currently.
Planning to start injectable estradiol 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Washington

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lauren Cirrincione, Assistant Professor, University of Washington

ClinicalTrials.gov Identifier:

NCT05469204

Other Study ID Numbers:

STUDY00014091

First Posted:

Jul 21, 2022

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Acetaminophen

Digoxin

Midazolam

Study Results

No Results Posted as of Jul 21, 2022