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 |