Comparability of Single Measurements of Serum Testosterone to the 24‐Hour Cavg in Patients Using Testosterone 2% Solution. (14th August 2014)

• Record Type: Journal Article
• Authors: Muram, David; Baygani, Simin
• Is Part Of: Journal of sexual medicine. Volume 11:Number 11(2014:Nov.)
• Page Start: 2826
• Page End: 2829
• Publication Date: 2014-08-14
• Subjects: Sexual disorders -- Periodicals; Sex -- Periodicals; Sexual health -- Periodicals; 616.69005
• DOI: 10.1111/jsm.12656
• Languages: English
• ISSNs: 1743-6095

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="jsm12656-sec-0001" sec-type="section"> <title>Introduction</title> <p>Efficacy of testosterone replacement therapy is determined by the proportion of men with 24‐hour average serum testosterone concentration (C<sub>avg</sub>) in the normal range. In clinical practice, monitoring and dose adjustments are based on single testosterone measurements; however, how single measurements reflect C<sub>avg</sub> is unclear.</p> </sec> <sec id="jsm12656-sec-0002" sec-type="section"> <title>Aim</title> <p>This post‐hoc analysis evaluated whether single serum testosterone measurements and C<sub>avg</sub> from the same day are both in the normal range in men receiving testosterone replacement therapy.</p> </sec> <sec id="jsm12656-sec-0003" sec-type="section"> <title>Methods</title> <p>In an open‐label, multicenter, titration trial, androgen‐deficient men (N = 155) were started on 60‐mg daily morning dose of testosterone 2% solution (Axiron®, Eli Lilly and Company, Indianapolis, Indiana, USA) applied to axillae (30 mg/axilla). Serum testosterone C<sub>avg</sub> was determined on Days 15, 60, and 120. If necessary, dose was adjusted to maintain C<sub>avg</sub> in the normal range (300–1, 050 ng/dL). This analysis included subjects (n = 105) whose C<sub>avg</sub> was within the normal range on Days 15, 60, and 120.</p> </sec> <sec id="jsm12656-sec-0004" sec-type="section"> <title>Main Outcome Measures</title> <p>Proportion of men with normal serum testosterone levels at 2, 4, or 8 hours post‐dose on Days 15, 60, and 120.</p> </sec> <sec id="jsm12656-sec-0005" sec-type="section"> <title>Results</title> <p>Greater than 93% of subjects had testosterone serum levels within the normal range 2, 4, or 8 hours post‐dose on at least 1 day. In subjects with blood samples available from Days 15 and 60 or Days 15 and 120, 71.1% to 79.8% had normal levels at 2, 4, or 8 hours post‐dose on both days, and in subjects with blood samples available from Days 15, 60, and 120, 63.9% to 68.8% had normal levels at 2, 4, or 8 hours post‐application on all 3 days.</p> </sec> <sec id="jsm12656-sec-0006" sec-type="section"> <title>Conclusion</title> <p>Less than 70% of single testosterone measurements made on 3 separate days were concordant with same‐day C<sub>avg</sub> for all 3 days. These findings, which are specific for testosterone 2% solution, indicate that single measurements do not always reflect the 24‐hour C<sub>avg</sub>, and may possibly lead to inappropriate dose adjustments. <bold>Muram D and Baygani S. Comparability of single measurements of serum testosterone to the 24‐hour C<sub>avg</sub> in patients using testosterone 2% solution. J Sex Med 2014;11:2826–2829.</bold></p> </sec> </abstract>