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news.Repros Therapeutics has reported phase III interim results from its trial of Androxal, a treatment for hypogonadism, which suggest a significant increase in testosterone.
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The study compares two doses of Androxal, 12.5mg and 25mg, to both placebo and open-label Androgel, Solvay’s testosterone replacement cream. Repros said that Androxal, which is an oral drug, met the trial’s primary endpoint by demonstrating non-inferiority in all parameters measured.
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, the company said.
Joseph Podolski, president and CEO of Repros, said: “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. 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.”
Repros said that it will seek a licensing partner for Androxal in Europe.