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This project will evaluate the effect of gender-affirming testosterone treatment on how other medications are processed by the body.
Gender-affirming hormone therapy may include testosterone, a hormone that the body creates and uses naturally. Testosterone is prepared as a medication that patients may take to increase hormone levels. Changes in testosterone concentrations in the body may affect how the body processes other medicines. The purpose of this study is to find out how testosterone therapy affects a single tracer dose of approved medicines in the blood (midazolam, digoxin, and acetaminophen) and to confirm testosterone treatment does not affect natural bacterial in the gut.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam oral solution | Drug | Oral syrup | ||
| Digoxin Oral Tablet | Drug | Oral tablet | ||
| Acetaminophen Oral Tablet | Drug | Oral tablet |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| midazolam Cmax ratio (treatment/control) | ratio of the maximum plasma concentration (Cmax) of midazolam in the presence to absence of gender-affirming testosterone treatment | 0-48 hours |
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Inclusion Criteria:
Exclusion Criteria:
Self-identify as transgender or trans nonbinary
Transgender adults planning to take testosterone treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Cirrincione, MPH,Pharm D | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41452771 | Derived | Hunter M, Coig R, Risler L, Patton KK, Narla RR, Greene DN, Burke AK, Micks E, Hebert MF, Cirrincione LR. Effect of Testosterone Therapy on Cytochrome P450 3A and P-Glycoprotein Activities Using Midazolam and Digoxin as Probe Substrates Among Transgender Adults. Pharmacotherapy. 2026 Feb;46(2):e70093. doi: 10.1002/phar.70093. Epub 2025 Dec 26. |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D004077 | Digoxin |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| D006571 | Heterocyclic Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |