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Objective: To observe the clinical effect of tadalafil combined with testosterone undecanoate on late-onset hypogonadism (LOH) in old and middle-aged males.

Methods: A total of 125 old and middle-aged (40 to 60 years) males with LOH were randomly assigned to a treatment group (n = 65) and a control group (n = 60) to be treated with tadalafil + testosterone undecanoate and testosterone undecanoate alone, respectively. We compared the levels of total testosterone (T), IIEF scores and the patients' sexual encounter profile (SEP) diaries before and 4 weeks after medication.

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