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Male Hormonal Deficiencies/Abnormalities

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September 20, 2004

Auxilium Pharmaceuticals has reported the results of a phase IV study of their topical testosterone therapy Testim, for the treatment of hypogonadism in men unable to achieve symptom amelioration with AndroGel, another topical testosterone therapeutic. The study found that Testim therapy was effective in treating symptoms of hypogonadism, significantly improving sexual function and satisfaction, compared with men remaining on a comparable dose of AndroGel. In addition, a significantly higher portion of subjects receiving Testim did not require dose escalation to achieve results at the end of the study period, compared with AndroGel. The study enrolled a total of 151 hypogonadal men who were refractory to or insufficiently served by AndroGel therapy; these subjects were randomized to receive either continued treatments with AndroGel or Testim once daily for 4 weeks.

August 9, 2004

Columbia Laboratories has reported the final results of their phase III study of their approved drug Striant, their testosterone buccal delivery system for the treatment of hypergonadism in men. Results have demonstrated that Striant is and efficacious in treating hypergonadism, with 86.6% of subjects achieving average serum testosterone levels within the literature-established standard physiological range. The drug was safe and generally well tolerated, with 16% of subjects reporting mild application site events. This open-label, multi-center study enrolled a total of 98 hypogonadal men (ages 20-75), who received twice daily intra-buccal applications of the drug for 12 weeks.

June 24, 2002

Phase III trial results suggest that long-term use of Unimed Pharmaceuticals' AndroGel (testosterone gel), a transdermal hormone replacement therapy, is safe and effective in men with low testosterone. The trial included 92 hypogonadal men with an average age of 52 years. Subjects received continuous replacement with testosterone gel for up to 42 months (average of 29 months). At six months, results showed that sexual motivation and performance improved significantly in subjects receiving testosterone gel, and this effect was maintained throughout treatment. An average decrease of 2.5 kg in fat mass was observed at 30 months, in addition to an average increase in lean body mass of 3.5 kg. Bone mineral density was increased at six months, and it remained increased by approximately 4% in the spine and 2% in the hip at 30 months.