一个新的口服睾酮Undecanoate制定恢复Hypogonadal男性睾酮正常浓度。
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Swerdloff RS,王C,白色的白平衡,Kaminetsky J,塞伊·基特曼MC, Longstreth是的,达德利再保险,Danoff TM
一个新的口服睾酮Undecanoate制定恢复Hypogonadal男性睾酮正常浓度。
中国性金属底座。2020年8月1日,105 (8)。pii: 5834353。doi: 10.1210 / clinem / dgaa238。
- PubMed ID
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32382745 (在PubMed]
- 文摘
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背景:一种新型配方口服睾酮(T) undecanoate (TU)在3期临床试验评估。目的:确定疗效,新的口服你制定的短期安全,结合美国当前的审批标准T替代疗法。设计:随机、active-controlled,开放研究。设置和病人:学术和私人临床实践的网站;登记病人临床hypogonadal男人18岁到65岁。方法:患者随机3:1口腔涂,规定(JATENZO (R);n = 166)或局部T产品每天一次(Axiron (R);n = 56) 3到4个月。剂量滴定法是基于平均T水平(Cavg)从串行计算药代动力学(PK)样本。T是液相色谱-光谱/质谱分析化验的。 Patients had 2 dose adjustment opportunities prior to final PK visit. Safety was assessed by standard clinical measures, including ambulatory blood pressure (BP). RESULTS: 87% of patients in both groups achieved mean T Cavg in the eugonadal range. Sodium fluoride-ethylenediamine tetra-acetate plasma T Cavg (mean +/- standard deviation) for the oral TU group was 403 +/- 128 ng/dL (~14 +/- 4 nmol/L); serum T equivalent, ~489 +/- 155 ng/dL (17 +/- 5 nmol/L); and topical T, 391 +/- 140 ng/dL (~14 +/- 5 nmol/L). Modeling/simulation of T PK data demonstrated that dose titration based on a single blood sample 4 to 6 h after oral TU dose yielded efficacy (93%) equivalent to Cavg-based titration (87%). Safety profiles were similar in both groups, but oral TU was associated with a mean increase in systolic BP of 3 to 5 mm Hg. CONCLUSION: A new oral TU formulation effectively restored T to mid-eugonadal levels in hypogonadal patients.
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