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news.Biopharmaceutical company Zonagen has released positive top-line results of an open-label study of Androxal, the company's candidate for the treatment of testosterone deficiency.
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The open-label study enrolled eight patients with normal testosterone levels, four with borderline testosterone levels, and one with low testosterone. Study subjects received 25mg of Androxal orally for two weeks and were monitored at the end of the dosing period and four weeks after dosing had stopped.
After two weeks on Androxal, all study subjects, including those that had normal testosterone levels at the start of the study, exhibited average testosterone levels within the normal range. The average change from baseline was 297.5 ng/dL of testosterone. Four weeks after the dosing period had concluded, all of the study subjects had returned to their baseline testosterone levels.
Dr Jean Fourcroy, a member of the board of Zonagen and the US Anti-Doping Agency, was pleased that the drug did not produce supra-normal levels of testosterone in the patients.
“Not only does Androxal exhibit the potential to restore normal testosterone levels in men experiencing secondary hypogonadism and consequently all the benefits that normalized male hormones afford, it appears that it does not offer the potential for abuse, although further studies need to substantiate this finding,” said Dr Fourcroy.