Effect of Gender-Affirming Estrogen Therapy on Drug Metabolism, Transport, and Gut Microbiota
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- midazolam AUC ratio (treatment/control)
Study Overview
Brief Summary
This project will evaluate the effect of estrogen treatment on how other medications are processed by the body.
Detailed Description
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
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Exclusion Criteria
- •Unwilling/unable to return for project follow-up visits.
- •Unwilling/unable to provide written informed consent.
Arms & Interventions
Healthy transgender adults
Healthy transgender adults will be studied on two separate study days and serve as their own control.
Intervention: Midazolam oral solution (Drug)
Healthy transgender adults
Healthy transgender adults will be studied on two separate study days and serve as their own control.
Intervention: Digoxin Oral Tablet (Drug)
Healthy transgender adults
Healthy transgender adults will be studied on two separate study days and serve as their own control.
Intervention: Acetaminophen Oral Tablet (Drug)
Healthy transgender adults
Healthy transgender adults will be studied on two separate study days and serve as their own control.
Intervention: Midazolam Injectable Solution (Drug)
Outcomes
Primary Outcomes
midazolam AUC ratio (treatment/control)
Time Frame: 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)
Time Frame: 0-48
ratio of digoxin renal clearance in the presence to absence of gender-affirming estradiol treatment.
Secondary Outcomes
- midazolam Cmax ratio (treatment/control)(0-6 hours)
Investigators
Lauren Cirrincione
Assistant Professor
University of Washington