Zonagen announces positive results of Androxal study for testosterone deficiency

By Lisa Kerner

Erie, Pa., Feb. 3 - Zonagen, Inc. said all 13 subjects in its Androxal study for testosterone deficiency exhibited average testosterone levels within the normal range after two weeks on Androxal.

Androxal is a proprietary, small molecule, orally active product designed to restore normal testosterone production, according to a company news release.

The open-label study enrolled eight patients with normal testosterone levels (greater than 350 and less than 1,100 ng/dL), four with borderline testosterone levels (250-350 ng/dL) and one with low testosterone (less than 250 ng/dL).

Study subjects received 25 mg of Androxal orally for two weeks and were monitored at the end of the dosing period and four weeks after dosing had stopped. All the subjects returned to their baseline testosterone levels four weeks after the dosing period, according to a company news release.

"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," Dr. Jean Fourcroy, member of the boards of Zonagen and the U.S. Anti-Doping Agency and a former FDA medical officer, said in the release.

Zonagen said its U.S. phase 1/2 study comparing Androxal to Androgel testosterone replacement therapy in 52 patients with low testosterone demonstrated both restored normal testosterone levels within two weeks of treatment. Androgel suppressed normal pituitary secretions; while Androxal was shown to restore normal pituitary signaling to the testes, eliminating the need for testosterone supplementation. Androxal was well tolerated over the course of the study.

Based on these phase 1/2 data, Zonagen is conducting a 200-patient phase 3 double-blind trial of Androxal versus placebo. The 24-week study will include an open-label arm of the commercially available Androgel. Initial data after 12 weeks of dosing is expected in the third quarter of 2006.

Zonagen is a biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive system disorders. The company is based in Waltham, Mass.

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