Pharmacokinetics of Modified Slow-Release Oral Testosterone Over 10 Days in Normal Men with Experimental Hypogonadism

    June 2011
    Ada P. Lee, Katya B. Rubinow, Richard V. Clark, Ralph B Caricofe, Mark Bush, Hui Zhi, Mara Y. Roth, Stephanie T. Page, William J. Bremner, John K. Amory
    TLDR The oral testosterone effectively increased testosterone levels and reduced SHBG, showing promise for treating testosterone deficiency.
    The study investigated the pharmacokinetics of a novel slow-release oral testosterone formulation in 12 healthy men with experimentally induced hypogonadism. Participants received 300 mg of oral testosterone three times daily for 9 days. Initially, serum testosterone levels were below 75 ng/dL, but the 24-hour average increased to 378 ng/dL on day 1 and slightly decreased to 315 ng/dL by day 9. Despite this decrease, free testosterone levels remained stable, and SHBG levels significantly decreased from 27 nmol/L to 19 nmol/L. DHT levels were within the reference range, and estradiol was slightly below it by day 9. The study concluded that this oral testosterone formulation effectively normalized serum testosterone and suppressed SHBG, suggesting potential efficacy for treating testosterone deficiency.
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