Conditions: Type 2 Diabetes Mellitus Secondary Hypogonadism
Keywords: Adult onset hypogonadotropic hypogonadism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 102
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism

Detailed description:
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.

Arms:
arm 1: Placebo arm 2: 12.5 mg/day arm 3: 25 mg/day

Interventions: intervention 1: Placebo intervention 2: Androxal
Intervention descriptions: intervention 1: Placebo capsule 1x daily for 3 months intervention 2: Capsules 12.5 mg or 25 mg 1x daily for 3 months

Protocol document: