script.reportAU
Endocrinology

Testosterone undecanoate

Brand: Reandron®

PBAC's latest decision on Testosterone undecanoate: Recommended (2005). Considered for Androgen deficiency in males with established pituitary or testicular disorders; Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings. Androgen deficiency is confirmed by testosterone less than 8 nmol per L, or 8-15 nmol per L with high LH (greater than 1.5 times the upper limit of the eugonadal reference range for young men); Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age.

PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2005
Submissions
1
2005 → 2005

Eligible population

Androgen deficiency in males with established pituitary or testicular disorders; Androgen deficiency in males 40 years and older who do not have established pituitary or testicular disorders other than aging, confirmed by at least 2 morning blood samples taken on different mornings. Androgen deficiency is confirmed by testosterone less than 8 nmol per L, or 8-15 nmol per L with high LH (greater than 1.5 times the upper limit of the eugonadal reference range for young men); Micropenis, pubertal induction, or constitutional delay of growth or puberty, in males under 18 years of age.

Therapy area
Endocrinology
Evidence base
RCT
Key trials
Von Eckardstein et al, Jockenovel F et al
Comparator
testosterone implant
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis used; no ICER calculated by design
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