Striant is a testosterone replacement produced by Auxilium Pharmaceuticals, Inc. The FDA approved its use for the treatment of hypogonadism in June 2003.
General Information
The Striant system of testosterone delivery is known as a “testosterone buccal system.” The word “buccal” refers to the mucosal lining between the cheek and the gum. Just like tobacco “dip” transmits its active compounds into the body via the mucosal lining, Striant delivers testosterone into the body via the mucosal tissues.
Two Studies on Striant
In 2004, Columbia Laboratories ran an open-label, multicenter study, testing Striant as a potential treatment for hypogonadism in 98 men, ages 20 to 75. All told, these men received inter buccal applications of the drug two times a day for 12 weeks. Over this time, this Phase III study demonstrated positive results: over 86% of the men achieved normalized testosterone levels, and only 16% complained about irritation at the site of the application.
A second study examined Striant transdermal Low T supplementation over a 7 day period. This trial was also a multicenter, open-label study; 84% subjects increased and normalized testosterone concentrations. The drug maker says that Striant is indicated for men suffering acquired or congenital hypogonadism as well as
hypogonadotropic hypogonadism.
Do note the short duration of both trials conducted. One trial only lasted for 7 days — hardly enough time to see anything but the most acute effects of the regimen. The other study did last about three months, but it involved fewer than 100 people, and it did not track (or report) cardiovascular risk disease factors.
Some science does suggest that testosterone supplementation may lead to development of chronic diseases, such as heart disease and stroke, clotting, renal and kidney diseases. The two studies cited above likely did not last long enough to test the effects of TRT (testosterone replacement therapy) on these risk factors.
Implications of the Trials
Unfortunately, basic questions of what constitutes good science can be easily forgotten, when drug companies want to rush new products to market. The 7 day study seems to indicate that testosterone supplementation is purely a good thing — the group saw improved markers, generally. However, perhaps such supplementation might suppress, over the long term, the body’s own natural ability to produce testosterone. Longer term studies on the safety of drugs like Striant are needed to minimize the likelihood of side effects.
For insight into your Testosterone case, call the Davis & Crump team now at 800-277-0300 or email us at info@daviscrump.com.
