Effect of Gender-Affirming Estrogen Therapy on Drug Metabolism, Transport, and Gut Microbiota
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- midazolam AUC ratio (treatment/control)
研究概览
简要总结
This project will evaluate the effect of estrogen treatment on how other medications are processed by the body.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Unwilling/unable to return for project follow-up visits.
- •Unwilling/unable to provide written informed consent.
研究组 & 干预措施
Healthy transgender adults
Healthy transgender adults will be studied on two separate study days and serve as their own control.
干预措施: Midazolam oral solution (Drug)
Healthy transgender adults
Healthy transgender adults will be studied on two separate study days and serve as their own control.
干预措施: Digoxin Oral Tablet (Drug)
Healthy transgender adults
Healthy transgender adults will be studied on two separate study days and serve as their own control.
干预措施: Acetaminophen Oral Tablet (Drug)
Healthy transgender adults
Healthy transgender adults will be studied on two separate study days and serve as their own control.
干预措施: Midazolam Injectable Solution (Drug)
结局指标
主要结局
midazolam AUC ratio (treatment/control)
时间窗: 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)
时间窗: 0-48
ratio of digoxin renal clearance in the presence to absence of gender-affirming estradiol treatment.
次要结局
- midazolam Cmax ratio (treatment/control)(0-6 hours)
研究者
Lauren Cirrincione
Assistant Professor
University of Washington