An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

To determine the safety profile of Androxal in men with secondary hypogonadism.

This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.

Inclusion Criteria:

• Successful completion of either ZA-301 or ZA-302

Exclusion Criteria:

• Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study