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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