Transgender Estradiol
关键词
抽象
描述
Patient will plan on being in the Adult Translational Research Unit (A-TRU) for 8 hours. They will be assigned to a suite. They will get 7 blood draws at hours 0,1,2,3,4,6,8 and vitals at the beginning of the visit. Vitals will include height, weight, blood pressure, respiration rate, and pulse. Subject is able to eat while in the A-TRU. Day 1 patient will take estradiol 1 mg ORALLY after time 0 blood draw. The medication will be given by registered nurse. A wash-out period of at least one week will allow for complete clearance of the exogenous oral estradiol before testing the pharmacokinetics of sublingual estradiol on the same ten patients in the same manner. Subject cannot take any hormone replacement therapy between their research appointments. On day 2, subject will take estradiol 1 mg SUBLINGUALLY after time 0 blood draw, supervised by a research team member to ensure proper dissolution. Blood will be drawn at hours 0,1,2,3,4,6,8 as on day 1.
日期
最后验证: | 12/31/2019 |
首次提交: | 07/24/2019 |
提交的预估入学人数: | 07/25/2019 |
首次发布: | 07/28/2019 |
上次提交的更新: | 01/16/2020 |
最近更新发布: | 01/21/2020 |
实际学习开始日期: | 09/22/2019 |
预计主要完成日期: | 03/31/2020 |
预计完成日期: | 04/30/2020 |
状况或疾病
干预/治疗
Drug: Estradiol
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Estradiol Subjects will take estradiol 1 mg orally after time 0 blood draw. They will get 7 blood draws at hours 0,1,2,3,4,6,8. A wash-out period of at least one week will allow for complete clearance of the exogenous oral estradiol before testing the pharmacokinetics of sublingual estradiol on the same ten patients in the same manner. On day 2 of study, subject will take estradiol 1 mg sublingually after time 0 blood draw, supervised by a research team member to ensure proper dissolution. Blood will be drawn at hours 0,1,2,3,4,6,8 as on day 1 of study. | Drug: Estradiol Patients will be given estradiol: 1 mg oral or 1 mg sublingual. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Transgender male-to-female - Naive to hormone therapy - English speaker - 18 years of age or older Exclusion Criteria: - History of hormone replacement therapy - Orchiectomy - Needle phobia - Serious bleeding condition - Active deep vein thrombosis, pulmonary embolism or history of these conditions - Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction) - Liver dysfunction or disease - History of breast cancer - Known sensitivity or allergy to any components of the medications used - Taking potent CYP3A4 inhibitors or inducers, as determined by team pharmacist - Taking a medication that may cause additional physical or mental harm if stopped |
结果
主要结果指标
1. Maximum serum concentration of estradiol [8 hours]
2. Half-life of estradiol [8 hours]
3. Area under the serum concentration versus time curve [8 hours]
4. Oral clearance of estradiol [8 hours]
5. Ratio of estrone to estradiol [8 hours]