Table 1 Exclusion criteria

Recent severe myocardial infarction or cerebrovascular accident

< 6 months

Cardiac failure, unless medically treated and not symptomatic

History or presence of any malignancy within the past 5 years, except for non-melanoma skin cancer. Subjects with ever history of testosterone (any hormone) dependent tumors.

Serious liver disease

ASAT, ALAT, AF, γGT >3 times upper limit of reference value (ASAT: 15–45 U/L; ALAT: 10–50 U/L; AF: 40–130 U/L ; γGT: 15–70 U/L:

Central Laboratory, UMC Utrecht)

Serious renal disease

Serum creatinine levels > 180 mol/L)

Epilepsy (or the use of anti-epileptic medication) or migraine > once a month

Diabetes mellitus

Diagnosed by physician or fasting glucose level of 6.9 mmol/L or higher (capillary)

Presence of any disease or condition that is clinically relevant and which might result in premature discontinuation, according to the opinion of the investigator.

Medication

Definition

Corticosteroid use

Orally: <6 months ago in dosage >7.5 mg a day, with the exception of short bouts of prednisone for the period of 7 days. Inhalation: <6 months ago in the dosage of >800 g a day)

Use of testosterone esters and alike substances within the past 60 days

Conditions for which increase of androgen-like substances are contra-indicated

PSA levels: age 60–69 years >4.5 μg/l;70 years and over >6.5 μg/L

Prostate hypertrophy in medical history Renal, liver function abnormalities or hematological abnormalities (Hb <7; Ht >0.50)

Prostate or breast cancer