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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