( nted This study points out the import...)Repros' Androxal Shows Highly Statistically Significant Positive,Effects in Men with Secondary Hypogonadism,Health

Although the syndrome of secondary hypogonadism is characterized by the objective measurements of low testosterone and gonadotrophic hormone levels it is recognized that in some men testosterone deficiency may be accompanied by a variety of symptoms related to decreased sexual function. This study did not require that any of those symptoms be present at enrollment as the primary inclusion criterion was low testosterone and low to normal LH. Nonetheless, as an exploratory exercise, three different patient questionnaires were included in the study to explore the relationship of these symptoms to low testosterone and the effects on these symptoms exhibited by increasing testosterone. The questionnaires that the subjects completed at monthly intervals were the "International Index of Erectile Dysfunction", "Sexual Desire Survey form, DISF-SR II" and the "Male Sexual Distress Scale" developed by Len Derogatis, PhD, Director, Center for Sexual Medicine at Sheppard Pratt Health Systems in Baltimore. Analysis of the MITT subjects indicate that in none of the symptom domains was there a difference in response from placebo although many of the treatment groups improved in comparison to baseline values. Although neither men treated with Androxal nor those treated with Androgel reported a significant increase in libido as determined using the DISF-SRII, both doses of Androxal performed comparably to Androgel. Likewise, although no statistically significant differences in distress, as measured by the MSDS scale, were recorded for men receiving Androxal or Androgel, both doses of Androxal performed in similar fashion to Androgel. Numerically, the 25mg dose of Androxal produced the greatest reduction in distress followed by the 12.5mg dose.

Overall the safety of Androxal was very similar to that of Androgel and placebo.
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