Conditions: Secondary Hypogonadism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief summary:
The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.

Detailed description:
Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.

Arms:
arm 1: Androxal 6.25 mg/day arm 2: Androxal 12.5 mg/day arm 3: Androxal 25 mg/day arm 4: AndroGel 5G topical testosterone

Interventions: intervention 1: Androxal (enclomiphene citrate) intervention 2: Testosterone
Intervention descriptions: intervention 1: capsule oral

1X a day 6 weeks intervention 2: topical gel

1X a day 6 weeks

Protocol document: