NCT05428215终止4 期
Comparison of Pharmacokinetics of 17-Beta-Estradiol Via Oral Administration With Sublingual Placement Versus Oral Administration With Swallowing of 17-Beta-estradiol in Male-to-Female Transgender Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- MaineHealth
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Estradiol absorption
研究概览
简要总结
This crossover study will investigate the pharmacokinetics of oral versus sublingual administration of 17-beta-estradiol in the trans-female population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •English speaker
- •Currently taking 17-beta-estradiol tablet daily via sublingual or oral route on dose therapeutic for gender-affirming therapy; steady dose for at least 4 weeks
- •Serum estradiol and testosterone levels within target therapeutic range (75-200 pg/mL and <55 ng/dL, respectively)
排除标准
- •Active or history of deep venous thrombosis/pulmonary embolism
- •Active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction)
- •Liver dysfunction
- •History of breast cancer
- •History of orchiectomy
- •Known sensitivity or allergy to any components of the study medication
- •Taking potent CYP3A4 inhibitors or inducers
研究组 & 干预措施
PO then SL
Active Comparator
Subjects will administer 17-beta-estradiol orally (PO) for Study Day 1-14, followed by administration of 17-beta-estradiol sublingually (SL) for Study Day 15-28.
干预措施: 17beta Estradiol (Drug)
SL then PO
Active Comparator
Subjects will administer 17-beta-estradiol sublingually (SL) for Study Day 1-14, followed by administration of 17-beta-estradiol orally (PO) for Study Day 15-28.
干预措施: 17beta Estradiol (Drug)
结局指标
主要结局
Estradiol absorption
时间窗: Over 24 hours
Mean area under the curve of estradiol
次要结局
- Serum estrone to estradiol ratio(Hours from administration of estradiol: 0, 1, 2, 4, 6, and 8 hours)
- Peak serum estradiol(Peak over 24 hour period)
- Serum estradiol Nadir(24 hours from last estradiol administration)
- Suppression of Testosterone(24 hours from last estradiol administration on Study Day 14 and 28)
- Sex hormone binding globulin(0 hours from estradiol administration on Study Day 14 and 28)
研究者
Katherine Davis
Physician- MH Obstetrics and Gynecology
MaineHealth
研究点 (1)
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