A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product

IF 2.6 4区 医学 Q2 UROLOGY & NEPHROLOGY
James S. Bernstein, Om P. Dhingra
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引用次数: 0

Abstract

Background:Oral testosterone undecanoate (TU) formulations may provide effective, safe, and easily titratable testosterone replacement therapy.Objective:Demonstrate efficacy and safety of a novel oral TU formulation.Design:An open-label, single-arm, multi-center trial treated 155 hypogonadal men for 180 days. Treatment began at 200 mg TU twice daily with meals; doses were titrated over two 28-day cycles to between 100 and 800 mg TU daily, measuring average testosterone (T Cavg) after 90 days. Ambulatory blood pressure monitoring (ABPM) occurred at baseline, 120, and 180 days.Methods:Titrations used a randomized blood sample taken 3-, 4-, or 5-h post-morning dose. Outcomes used sodium fluoride/ethylenediaminetetraacetate plasma testosterone (T) values; serum results were also reported. Blood pressure (ABPM and in-clinic) was evaluated for change from baseline.Results:After titration, 87.8% of KYZATREX™ treated participants (worse-case scenario) and 96.1% of 90-day completers achieved eugonadal mean plasma T values. Serum T Cavg was 452 ng/dL and maximum T concentrations (T Cmax) met all FDA criteria. Participant eugonadal percentages were comparable across subgroups for age, weight, and body mass index. Diet had no effect on participant eugonadal percentages. KYZATREX was well tolerated, with no drug-related serious adverse events (SAE) and one adverse drug reaction (hypertension) observed in 2% or more of participants. Systolic ambulatory blood pressure increased 1.7 mmHg (95% confidence interval: 0.3–3.1). At baseline, 36% of 155 participants were receiving anti-hypertensive medication and 22% were diabetic. No dose increases occurred in existing anti-hypertensive medication; five participants (3.2%) started anti-hypertensive medication.Conclusion:KYZATREX provided safe and effective testosterone levels within the normal range in hypogonadal male study participants.Clinical trial registration:URL: https://clinicaltrials.gov/ unique identifier NCT04467697, conducted under NCT03198728. Post-completion, clinicaltrials.gov requested creation of the separate NCT04467697 identifier. All subjects were recruited under NCT03198728.
为期 6 个月的宽剂量范围十一酸睾酮口服产品 III 期单臂试验
背景:口服十一酸睾酮(TU)制剂可提供有效、安全且易于滴定的睾酮替代疗法。目标:展示新型口服 TU 制剂的疗效和安全性。设计:一项开放标签、单臂、多中心试验,对 155 名性腺功能减退的男性进行了 180 天的治疗。治疗开始时每天两次,每次200毫克TU,餐后服用;剂量在两个28天的周期内滴定为每天100至800毫克TU,90天后测量平均睾酮(T Cavg)。在基线、120 天和 180 天时进行动态血压监测 (ABPM)。结果采用氟化钠/乙二胺四乙酸盐血浆睾酮(T)值;同时报告血清结果。结果:滴定后,87.8% 的 KYZATREX™ 治疗参与者(最差情况)和 96.1% 的 90 天完成者达到了优生优育的平均血浆睾酮值。血清 T Cavg 为 452 ng/dL,最大 T 浓度 (T Cmax) 符合 FDA 的所有标准。在不同年龄、体重和体重指数的亚组中,参与者的优生率相当。饮食对参与者的性腺百分比没有影响。KYZATREX 的耐受性良好,没有出现与药物相关的严重不良事件 (SAE),2% 或更多的参与者出现了一种药物不良反应(高血压)。收缩压上升了 1.7 mmHg(95% 置信区间:0.3-3.1)。基线时,155 名参与者中有 36% 正在服用抗高血压药物,22% 患有糖尿病。结论:KYZATREX为性腺功能低下的男性研究参与者提供了安全有效的睾酮水平,且在正常范围内。临床试验注册:网址:https://clinicaltrials.gov/ 唯一标识符NCT04467697,在NCT03198728下进行。临床试验完成后,clinicaltrials.gov要求创建单独的NCT04467697标识符。所有受试者都是在 NCT03198728 下招募的。
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来源期刊
CiteScore
3.70
自引率
0.00%
发文量
39
审稿时长
10 weeks
期刊介绍: Therapeutic Advances in Urology delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of urology. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in urology, providing a forum in print and online for publishing the highest quality articles in this area. The editors welcome articles of current interest across all areas of urology, including treatment of urological disorders, with a focus on emerging pharmacological therapies.
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