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

Inclusion Criteria:

• Subjects were at least 50 years of age
• A body mass index (BMI) between 18 and 34 kg/m^2
• Symptoms of androgen deficiency (as indicated by a positive Androgen Deficiency in Aging Males (ADAM) questionnaire)
• Calculated free testosterone measurement of <0.26 nmol/L in the morning

Exclusion Criteria:

• History or current diagnosis of breast or prostate cancer
• any clinically significant abnormal finding on physical examination including the prostate
• Clinical symptoms of obstructive benign prostate hyperplasia (International Prostate Symptom Score (IPSS) >14)
• Prostate specific antigen (PSA) level > 4 ng/mL at screening
• Cause of androgen deficiency other than aging, e.g. 'classical' diagnosis of primary or secondary hypogonadism
• Hyperprolactinaemia or treatment with prolactin-lowering drugs
• History of known chronic polycythemia and/or hematocrit >50% at screening
• History or presence of severe sleep apnea
• Unstable or untreated endocrine disorders
• History or presence of clinically significant depression or other psychiatric disorder or any clinically relevant cardiovascular, cerebrovascular, endocrine, hepatic, renal or hematological disease, thromboembolism/thrombosis etc. which, in the opinion of the investigator, might compromise the subject's participation in the trial
• Use of medication that would interfere with the efficacy and safety objectives of the trial