A 54 week treatment, randomized, multi center, double blind, placebo controlled study to assess the safety and efficacy of NEBIDO 1000 mg (4 ml) in elderly men with symptomatic late onset hypogonadism (SLOH)

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Extract

Efficacy and safety of NEBIDO in men with symptomatic late onset hypogonadism (SLOH) as characterized in the protocol inclusion criteria: To assess the change from baseline in lean body mass after 54 weeks of treatment with NEBIDO compared to placebo, measured by dual energy X-ray absorptiometry (DEXA). Safety parameters • Adverse event • Clinical laboratory evaluations (i.e. FBC, creatinine, glucose, potassium, calcium and HbA1c) vital signs, physical examination findings, and other observations related to safety e.g. DRE and IPSS • Standard laboratory tests for androgen treatment: prostate specific antigen (PSA); hemoglobin; hematocrit, • Laboratory tests for lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol and Triglycerides) and liver function tests (aspartate aminotransferase [AST] and alanine transaminase [ALT])

Inclusion criteria

Symptomatic late onset hypogonadism

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A 54 week treatment, randomized, multi center, double blind, placebo controlled study to assess the safety and efficacy of NEBIDO 1000 mg (4 ml) in elderly men with symptomatic late onset hypogonadism...