Zonagen receives review board approval for phase 3 study of Androxal

By Lisa Kerner

Erie, Pa., Jan. 9 - Zonagen, Inc. has received Investigational Review Board approval for the start of its phase 3 study of Androxal.

Androxal is a once-a-day oral therapy for the treatment of testosterone deficiency, resulting from secondary hypogonadism, most common in aging males.

The 200-patient trial will be conducted in the United States and will enroll patients at up to 20 clinical sites. It is designed to assess the safety of Androxal and its efficacy in restoring normal pituitary and testicular function.

The double-blind study will test two doses of Androxal versus a placebo over a 24-week period. It will include an open-label arm with the commercially available drug Androgel.

Doses for the phase 3 trial were previously tested in a 52-patient, two-week study of Androxal in men in the United States with low testosterone. In the study, Androxal was well tolerated and demonstrated positive effects on restoring normal testosterone levels within two weeks. The study also found that Androgel, while replacing testosterone levels, further suppressed normal pituitary secretions.

Initial data after 12 weeks of dosing is expected in late summer. A total of three phase 3 studies are planned.

Zonagen, a clinical stage biopharmaceutical company, develops new drugs to treat hormonal and reproductive system disorders. The company has its headquarters in The Woodlands, Texas.

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