In this study we have evaluated the effects of three different doses of oral testosterone undecanoate in aging men presenting with a combination of symptoms suggestive of hypogonadism and low blood levels of the male hormone testosterone. Specifically, we have studied the effects on: * symptoms suggestive of low testosterone levels * blood testosterone and other hormone levels * bone mass * muscle mass and fat mass * muscle strength * prostate * lipids, hematocrit
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
322
treatment for 12 months with oral TU 80 mg/d, oral TU 160 mg/d or oral TU 240 mg/d in divided doses
treatment for 12 months with placebo in divided doses
Change from baseline on the total score of the AMS rating scale
Time frame: Month 6
Effects on AMS rating scale, bone mineral density, bone markers, muscle and fat mass, muscle strength, hematocrit, endocrine parameters, PSA, IPSS and lipids
Time frame: Month 12
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