Pharmacokinetics And Relative Bioavailability Of Absorbed Testosterone After Administration Of A 1.62% Testosterone Gel To Different Application Sites In Men With Hypogonadism

生物利用度 睾酮(贴片) 医学 药代动力学 交叉研究 内科学 肩膀 二氢睾酮 内分泌学 曲线下面积 腹部 雄激素 药理学 激素 外科 替代医学 病理 安慰剂
作者
Jodi L. Miller,Margaret Britto,Suzanna Fitzpatrick,Cecilia McWhirter,Samuel A Testino,John J. Brennan,Troy L. ZumBrunnen
出处
期刊:Endocrine Practice [Elsevier BV]
卷期号:17 (4): 574-583 被引量:23
标识
DOI:10.4158/ep10192.or
摘要

ABSTRACT

Objective

To determine the pharmacokinetics, bioavailability, and safety of a new formulation (1.62%) of testosterone gel that produces eugonadal serum testosterone levels with use of a lower amount of gel than the currently available 1% gels.

Methods

In an open-label, randomized, 3-way crossover study, 36 male patients with hypogonadism applied 5 g of 1.62% testosterone gel (81 mg of testosterone) once daily to the abdomen, to the upper arms/shoulders, or alternating between both sites per an established schedule for 7 days. Serum levels of testosterone, dihydrotestosterone, and estradiol were measured and used to compare the pharmacokinetics and bioavailability of the 3 treatments.

Results

Each application method produced average serum testosterone concentrations within the eugonadal range (300 to 1,000 ng/dL), and steady-state testosterone concentrations were achieved after 2 days of gel application to either the abdomen or the upper arms/shoulders. When testosterone gel was applied to the abdomen, approximately 30% to 40% lower bioavailability (based on area under the serum concentration-time curve from 0 to 24 hours) was observed in comparison with application to the upper arms/shoulders. The 1.62% testosterone gel was found to be safe and well tolerated in men with hypogonadism.

Conclusion

Although lower testosterone bioavailability was observed after abdominal application of 1.62% testosterone gel in comparison with application to the upper arms/shoulders, application to either site yielded eugonadal levels of serum testosterone. (Endocr Pract. 2011;17:574-583)

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