Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.

Inclusion Criteria:

• Total serum testosterone concentrations < 300 ng/dL at baseline

Exclusion Criteria:

• Presence or history of prostate cancer
• Elevated PSA > 3.5 ng/mL

Additional inclusion and exclusion criteria may apply.