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Table 1 Eligibility Criteria

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

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 inclusiona
  1. 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