A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention)

Table 1 Eligibility Criteria

Inclusion criteria - Age > 18 years and <65 years - Previous treatment for testicular cancer - No signs of relapse 1 year after the last treatment (orchiectomy, radiotherapy, chemotherapy) - Serum free testosterone < the age-adjusted mean value and >2 standard deviations (SD) below the age-adjusted mean value - Serum luteinizing hormone (LH) > 2 SD above the age-adjusted mean value
Exclusion criteria - Testosterone treatment within the last 6 months - Contraindications to testosterone treatment: (prostate cancer, prostate specific antigen (PSA) > 4 ng/mL), malignancy suspect prostate by digital rectal examination (ALT) > 1.5 upper limit of normal, erythrocyte volume fraction (EVF) > 50%, breast cancer - Symptomatic obstructive sleep apnoea syndrome - Heart failure > New York Heart Association class II - Uncontrolled hypertension: (Systolic blood pressure > 160 mmHg despite antihypertensive treatment, measured at two separate occasions) - Inability to understand information about the trial - Participation in any other clinical trial - Allergy for the active substance or additives in Tostran or placebo. - Known diabetes mellitus, or diabetes mellitus detected at screening or at baseline - Paternity wish at the time of inclusion^a

^aIf there is any doubt about paternity wish at the time of inclusion, the study subject should give a semen sample for analysis. If the semen sample shows any viable sperm cells, the study subject will be excluded

ISSN: 1471-2407