Objective: To assess the efficacy and safety of testosterone replacement in males with late-onset hypogonadism compared to hypogonadal men without replacement, and controls, during six months. Methods: We assessed, through ADAM, AMS, IIEF-5 and SF-36 questionnaires, and through clinical and laboratorial examinations, 62 patients divided into three groups: 17 hypogonadal males (HR) used intramuscular testosterone every three weeks; 14 hypogonadal males (HV) and 31 non-hypogonadal males (CV) used oral vitamins daily. Results: When compared to others, HR group obtained libido improvement assessed by ADAM 1 (p = 0.004), and borderline sexual potency improvement assessed by IIEF-5 (p = 0.053), besides a decrease in waist circumference after eight weeks (p = 0.018). The remaining parameters did not differ between the groups. PSA and hematocrit remained stable in those using testosterone. Conclusion: Six months of testosterone replacement improved sexuality and body composition, with prostatic and hematological safety. KeywordsTestosterone replacement therapy; late onset hypogonadism; andropause; libido; body composition; waist circumference resumo Objetivo: Avaliar a eficácia e a segurança da reposição de testosterona em homens com hipogonadismo tardio comparados a hipogonádicos sem reposição e controles, durante seis meses. Métodos: Mediante os questionários ADAM, AMS, IIEF-5 e SF-36, foram feitos exame clínico e laboratorial em 62 pacientes divididos em três grupos: 17 hipogonádicos (HR) usaram testosterona intramuscular a cada três semanas; 14 hipogonádicos (HV) e 31 não hipogonádi-cos (CV) usaram vitaminas via oral diariamente. Resultados: Comparado aos demais, o grupo HR obteve melhora da libido avaliada pelo ADAM 1 (p = 0,004) e melhora limítrofe da potência sexual avaliada pelo IIEF-5 (p = 0.053), além de diminuição da cintura a partir da oitava semana (p = 0,018). Os demais parâmetros não foram diferentes entre os grupos. PSA e hematócrito se mantiveram estáveis nos que usaram testosterona. Conclusão: A reposição de testosterona durante seis meses melhorou a sexualidade e a composição corporal, com segurança prostática e hematológica. Arq Bras Endocrinol Metab. 2009;53(8):996-1004 Descritores
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