A Houston company starts Phase III of testosterone oral product

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Zonagen Receives IRB Approval to Commence Phase III Study of Androxal for the Treatment of Testosterone Deficiency http://www.zonagen.com/html/product_pipeline.htm#androxal

THE WOODLANDS, Texas--(BUSINESS WIRE)--Jan. 9, 2006--Zonagen, Inc.(Nasdaq:ZONA)(PCX:ZONA), a biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive systemdisorders, today announced that the Company has received InvestigationalReview Board (IRB) approval for the start of its Phase III study ofAndroxal, a once-a-day oral therapy for the treatment of testosteronedeficiency resulting from a condition known as secondary hypogonadism. The 200 patient trial will be conducted in the U.S. under an existing U.S.Investigational New Drug application and will enroll patients at up to 20clinical sites. The 200 patient Androxal study is designed to assess both the safety ofAndroxal and its efficacy in restoring normal pituitary and testicularfunction in men that are hypogonadal due to secondary hypogonadism.Secondary hypogonadism is a failure of appropriate signaling from thepituitary to the testes. The condition is most common in aging males but can result from a variety of causes, including the use of androgens. The double-blind study will test two doses of Androxal versus placebo andwill include an open-label arm of the commercially available drugAndrogel®. The dosing is of 24-week duration with an efficacy assessment made at 12 weeks. Initial data after 12 weeks of dosing is anticipated in late summer 2006. The extension of the trial dosing to 24 weeks is to satisfy the U.S. Food and Drug Administration (FDA) request regarding the safety of restoring normal testicular function as compared to placebo or the currently approved testosterone replacement therapies. We believe that at least two additional Phase III pivotal studies beyond the currently planned study will be required before an NDA can be submitted.

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