Effect of Gender-Affirming Testosterone Therapy on Drug Metabolism, Transport, and Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- midazolam AUC ratio (treatment/control)
研究概览
简要总结
This project will evaluate the effect of gender-affirming testosterone treatment on how other medications are processed by the body.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identified trans* adult at least 18 years of age.
- •Not taking testosterone treatment currently.
- •Planning to start testosterone treatment through care provider 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.
结局指标
主要结局
midazolam AUC ratio (treatment/control)
时间窗: 0-48 hours
ratio of the area under of the plasma concentration time curve (AUC) of midazolam in the presence to absence of gender-affirming testosterone treatment.
次要结局
- midazolam Cmax ratio (treatment/control)(0-48 hours)
研究者
Lauren Cirrincione
Assistant Professor, Pharmacy
University of Washington