ZA-303: Enclomiphene Citrate Treatment (H-32731)
This study is being conducted to assess the effects of Androxal® on bone mineral density in men with low testosterone hormone levels. The capsule form of Androxal® (the study drug) is considered investigational which means that it has not been approved by the FDA for this use.
Men ages 18 to 60 diagnosed with low testosterone levels will be randomized to one of 3 groups of study drugs. Randomization is by chance, like the flip of a coin. There will be a 2 in 3 chance of receiving Androxal® and there will be a 1 in 3 chance of receiving placebo (placebo contains no active ingredient).
This study will last approximately 14 months and involve up to 12 visits. Participants will be asked to make regularly scheduled visits to the study site.