GYNEX' SUBLINGUAL TESTOSTERONE

4 October 1992

Gynex Pharmaceuticals has announced that it has begun a Phase III clinical trial of its drug Androtest-SL (sublingual testosterone) for the treatment of men with hypogonadism caused by reduced testosterone levels. It is estimated that as many as 400,000 Americans suffer from the condition, which is associated with loss of libido, impotence, insufficient muscle development and bone loss.

At the moment, testosterone is given via intramuscular injection every two to three weeks. Gynex feels that Androtest-SL, given once-daily, will be far preferable to both physicians and patients, because of its ease of administration. The Phase III study will be carried out in two centers in California, USA.

Gynex is also looking at using Androtest-SL for hormone replacement therapy in older men. Production of testosterone is known to decline as men advance in years, and may in some cases lead to a situation where the hormone levels recede far enough to cause some of the symptoms of hypogonadism. A number of government studies are being conducted by independent researchers to determine whether this therapy can help alleviate these and other negative aspects of aging.

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