Androxal

[xxx777]

I am sorry I cannot post a link as I got this article from my brokers web site which would not allow access. I know the protocol here is to provide a link if at all possible.

Anyway I am wondering if anyone here is tracking this new oral drug Androxal which is proving to be more effective then Androgel at increasing testosterone levels . Somehow it causes the production of endogenous test. Is this the same as HCG or does it repair the HPTA itself I wonder? All I can find are similar press releases which don't say much.

Exciting if it really works.

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Repros' Androxal Shows Noninferiority in Interim Phase 3 Analysis
6:00a ET December 20, 2006 (Business Wire)

Repros Therapeutics Inc. (NasdaqGM:RPRX)(PCX:RPRX) announced interim results of a U.S. Phase 3 study of Androxal(TM), an oral drug that restores normal testicular function, for the treatment of testosterone deficiency in men with secondary hypogonadism. The Company has closed enrollment in the trial at 194 patients. These results suggest that, at this time in the study, treatment with Androxal results in a statistically significant increase in mean testosterone. Further, Androxal demonstrates non-inferiority in all parameters measured, in all the primary endpoints of the study, compared to Androgel(R), a commercially available testosterone replacement cream marketed for the treatment of low testosterone .

Study Details and Results

This double-blind study compares two doses of Androxal, 12.5 mg and 25 mg, to both placebo and open-label Androgel(R), which was dosed according to physician instructions (including use of higher doses where indicated). Testosterone levels as well as subjective measures of libido and distress were assessed in study participants. The study's primary endpoint is non-inferiority of Androxal in comparison to Androgel. To date, 112 patients have completed 12 weeks of treatment and have had analyses completed for their study parameters.

In this interim analysis, men treated with 12.5 mg of Androxal experienced an increase in mean testosterone of 210 ng/dl (p value less than 0.0001) over baseline; those treated with 25 mg of Androxal experienced an increase of 241 ng/dl (p value less than 0.0001) over baseline; and those treated with open-label Androgel, administered at any dose, experienced an increase of 167 ng/dl (p value = 0.0002) over baseline. As expected, men receiving placebo experienced no statistically significant change in mean testosterone.

Although neither men treated with Androxal nor those treated with Androgel reported a significant increase in libido as determined using the DISF-SRII scale at this interim analysis, 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 25 mg dose of Androxal produced the greatest reduction in distress followed by the 12.5 mg dose. However, as noted above the size of the data set at this time did not allow for a statistically significant difference compared to placebo. Both the DISF-SRII, a validated libido questionnaire and the Male Sexual Dysfunction Survey (MSDS), a questionnaire focusing on distress associated with low testosterone, have been developed by Dr. Leonard DeRogatis, Ph.D., Director of the Center for Sexual Medicine at Sheppard Pratt, a private non-profit provider of behavioral health services based in Maryland.

"We are very encouraged by these data," commented Joseph Podolski, President and CEO of Repros. "Androxal appears, at this interim analysis, to have met the study's primary endpoint, so we certainly look forward to concluding this trial and analyzing the full and complete data set. Moreover, we were impressed by the consistency with which Androxal produced increases in mean testosterone in men taking either dose. We anticipate completing this trial in the first half of 2007 and will provide our shareholders with an update on the final analysis when it is available." Mr. Podolski continued, "With these encouraging results in hand, we will seek to identify a licensing partner for Androxal in Europe."

Repros anticipates conducting at least two additional Phase 3 pivotal studies before submitting a New Drug Application to the U.S. Food and Drug Administration.

[zaggahamma]

haven't heard of it myself but subscribed