( l (measurements for patients thatcompl...)Repros' Androxal Shows Highly Statistically Significant Positive,Effects in Men with Secondary Hypogonadism,Health

l (measurements for patients that completed month three equally demonstrated non-inferiority). Both doses of Androxal were superior to placebo (p less than 0.0001). At month three, the mean improvement in testosterone levels was 184.3 and 259.2 ng/dl for both the 12.5mg and 25mg dose of Androxal, respectively. The improvement for Androgel and placebo were 168.3 and 6.4 ng/dl, respectively. The 25mg dose of Androxal achieved a statistically significant improvement compared to Androgel (p = 0.036). The improvement in total testosterone level was maintained for the entire six month double blind period and the proportions of subjects achieving testosterone levels greater than 300 ng/dl were 70.5%, 84%, 53.2% and 31.9% for 12.5mg, 25mg, Androgel and placebo arms, respectively.

The improvement in total testosterone in the Androxal arms was the result of normalization of the pituitary gonadotrophic hormones LH (luteinizing hormone) and FSH (follicle stimulating hormone). Consistent with the diagnosis of secondary hypogonadism, LH values at entry were in the low normal range with a median value of 3.7 mIU/mL. After three months of treatment LH increased to normal values of 5.8 and 8.1 in the Androxal 12.5mg and 25mg groups, respectively, remained unchanged at 3.3 in the placebo group but decreased significantly to 0.3 in the Androgel group, a value below the normal range. After six months of treatment the values for the four treatment groups were similar to the values at three months. The trends for FSH increasing from low to normal values in the Androxal treatment groups were similar to the LH responses. FSH decreased statistically significantly (p less than 0.0001) in the Androgel group and remained unchanged in the placebo patients. The sex hormone responses to Androxal treatment are consistent with normalizing pituitary function.

Jean Fourcroy, MD, PhD, Repros Therapeutics Board member and former Medical Officer with the Food and Drug Administration, comme
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