Exploratory Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus and Secondary Hypogonadism or Adult-Onset Idiopathic Hypogonadotropic Hypogonadism

A phase IIB, multi-center, randomized, parallel, placebo- and active-controlled trial in
adult male subjects with secondary hypogonadism who have been treated with OHAs but are not
in glycemic control. All subjects currently treated with exogenous testosterone will
discontinue at screening for at least 21 days and remain off testosterone for the course of
the study. One hundred twenty to 150 subjects will be randomly assigned to one of three
treatment groups according to a 1:1:1 ratio. Subjects will receive one of two dose
strengths of Androxal or placebo in addition to their usual dose of mono- or combination
OHAs for three months. Following an initial screening period, subjects will return monthly
for 3 months and 1 month later for a follow-up visit.