Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)
Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203)
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