Effect of Treatment on Bone Mineral Density Clinical Trial
Official title:
A 12 Month, Single Blind, Placebo Controlled, Phase III Study to Assess the Effects of Enclomiphene Citrate Treatment On Bone Mineral Density in Men With Secondary Hypogonadism
To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism.
This study is a phase III single-blind placebo-controlled safety study with a 52 week active dosing period with Androxal. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy eye exams, clinical laboratory tests, DEXA scanning, lean soft tissue assessment (LST), and adverse event reporting. Results will be compared to an age-matched placebo group. ;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)