Conditions: Secondary Hypogonadism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief summary:
The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

Detailed description:
This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.

Arms:
arm 1: Placebo arm 2: Testim (topical testosterone) arm 3: Androxal 12.5 mg/day arm 4: Androxal 25 mg/day

Interventions: intervention 1: Placebo intervention 2: topical testosterone intervention 3: Androxal
Intervention descriptions: intervention 1: Placebo capsule 1x daily for 3 months intervention 2: testosterone gel applied 1x daily for 3 months intervention 3: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Protocol document: