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AndroGel Offers New Option for Testosterone Replacement

March 31, 2000

The U.S. Food and Drug Administration announced on 2-29-2000 that AndroGel has been approved for use as a testosterone replacement therapy in men with low testosterone. AndroGel is a clear, colorless, topical gel that is applied to the shoulders, upper arms, or abdomen once a day. The gel dries within minutes during which time the testosterone is absorbed into the skin. The skin then serves as a reservoir for the testosterone that is slowly released into the bloodstream.

Low testosterone, clinically referred to as hypogonadism, affects many people living with HIV. Until now, the only replacement therapies that have been available have been intra-muscular injections (which are very painful and involve large needles), or testosterone patches (which sometimes cause severe skin irritation where the patch is placed.) AndroGel will offer people needing regular testosterone replacement therapy an easier alternative to those previously available.

Clinical data from phase III studies conducted in men with low testosterone showed that AndroGel raised testosterone levels quickly, and maintained it within normal range. The study reported that AndroGel also "increased sex drive, bone mineral density, and lean body mass." Complete study findings are to be reported in June 2000 and the pharmaceutical company, Unimed, expects to have the product available to consumers (by prescription) in mid-summer 2000. For more information on this product you can view the companies website at: http://www.unimed.com.


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