Safe, effective and selective oral androgen therapy with the combination of high-dose oral testosterone or testosterone esters and a dual 5-alpha reductase inhibitor

Introduction Men with a testosterone deficiency may have symptoms of depression, reduced libido, and low energy. They may suffer from anemia, osteoporosis and debilitating muscle weakness. Testosterone replacement therapy can improve well-being, maintain bone and muscle mass, and retain healthy sexual function. In the U.S., only intramuscular injections, transdermal patches or gels are safely used to administer testosterone. The intramuscular injections must be given every 1-3 weeks to maintain normal serum levels and can be painful. Testosterone patches may cause moderate to severe skin reactions in more than half of subjects due to the vehicle that facilitates testosterone absorption across the skin. The testosterone gel is effective but expensive and care must be taken to avoid inadvertent exposure to women and children. Technology description Dr. John Amory and Dr. William Bremner have developed a practical means of oral androgen therapy. Modulators dutasteride or finasteride are used which greatly increase the bioavailability of testosterone orally administered in an oil vehicle. In addition, oral testosterone taken with modulators significantly reduces levels of the androgen dihydrotestosterone (DHT). DHT levels above the normal range, a side effect of oral testosterone therapy currently used clinically in Europe, may increase risk of prostate disease. Business Opportunity The testosterone replacement therapy market is currently worth $600 million globally with 5% of men with testosterone levels below the normal range using replacement therapy. As the population grows and demographics shift towards an aging population, this number is predicted to grow. In addition, the market is anticipated to grow with the advent of new and effective drug delivery methods with minimal side effects. Orally administered androgen therapy is more convenient, safe, effective and selective than currently available treatments. Intellectual Property Position Issued US Patent 7,138,389: Oral Androgen Therapy Using Modulators of Testosterone Bioavailability. 11/21/2006 Related Publication(s)
J Clin Endocrinol Metab. 2005 May;90(5):2610-7 For more information on this technology contact:
Angela Loihl, Ph.D. Licensing Officer UW TechTransfer, Invention Licensing [email protected] 206-543-3970

Type of Offer: Licensing



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