Conditions: Secondary Hypogonadism
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 499
Healthy volunteers: no

Brief summary:
ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

Detailed description:
This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.

Arms:
arm 1: Androxal 12.5 mg daily arm 2: Androxal 25 mg daily

Interventions: intervention 1: Androxal
Intervention descriptions: intervention 1: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Protocol document: