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Table 2 Dose adjustments and dose modifications due to safety issues

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

Dose adjustment Dose modifications Follow-up
Starting dose: 10 mg daily
(one depression of the piston)
  
Week 2: 20 mg daily
(two depressions of the piston)
  
Week 4: 30 mg daily
(three depressions of the piston)
  
Week 8: 40 mg daily
(four depressions of the piston)
  
52 weeks: End of treatment   
Safety issues   
 Increase in free testosterone to >3 SD above the age-adjusted mean Dose adjustment to previous treatment step Measurement of free testosterone and LH after 14 days and dose adjustment accordingly
 Decrease in LH to < −2 SD below the age-adjusted mean Dose adjustment to previous treatment step Measurement of free testosterone and LH after 14 days and dose adjustment accordingly
 Increase in EVF to >52% Dose adjustment to previous treatment step Measurement of EVF after 14 days and dose adjustment accordingly
 Plasma PSA > 4 ng/mL at any visit. A PSA increase of >1 ng/mL at visit 7 or visit 8, using plasma PSA at visit 6 as baseline Referral for urological consultation According to urological consultation: Stop treatment if increased risk of prostate cancer. Continue treatment at the same treatment step if there is no increased risk of prostate cancer
 An increase in systolic blood pressure > 20 mmHg confirmed at two separate measurements despite antihypertensive therapy, if not due to free testosterone being >3 SD from the age-adjusted mean Stop treatment Measurement of blood pressure after 14 days. If still elevated referral to general practitioner
 ALT increase >1.5 upper reference level Stop treatment Measurement of ALT after 14 days. If still elevated referral for hepatological consultation
 Any other exclusion criteria becoming apparent during treatment Stop treatment