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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23GM147350 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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This project will evaluate the effect of estrogen treatment on how other medications are processed by the body.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy transgender adults | Other | Healthy transgender adults will be studied on two separate study days and serve as their own control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam oral solution | Drug | 2 mg single-dose before and during estradiol treatment. |
|
| 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 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 |
| 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 estradiol treatment | 0-6 hours |
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Inclusion Criteria:
Exclusion Criteria:
Self-identify as transgender or trans nonbinary
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 28, 2025 | Jan 7, 2026 | ICF_000.pdf |
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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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| Digoxin Oral Tablet | Drug | 0.25 mg single-dose before and during estradiol treatment. |
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| Acetaminophen Oral Tablet | Drug | 500 mg single-dose before and during estradiol treatment. |
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| Midazolam Injectable Solution | Drug | 1 mg intravenous single-dose before and during estradiol treatment. |
|
| 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 |