Randomized cross-over clinical trial of injectable vs. implantable depot testosterone for maintenance of testosterone replacement therapy in androgen deficient men.
BACKGROUND
Life-long testosterone replacement therapy (TRT) for younger men with organic androgen deficiency is best provided by depot testosterone (T) products. This study compared directly the two long-acting depot T products, subdermal T implants (TI) and injectable T undecanoate (TU) for maintenance of TRT.


METHODS
Men with organic androgen deficiency (n = 38) undergoing regular TRT at an academic Andrology centre were recruited for a two period, randomized sequence, cross-over clinical trial without intervening wash-out period of TRT maintenance.


RESULTS
For both depot T products, their pharmacokinetics and pharmacodynamics were evaluated using a range of androgen sensitive clinical, laboratory and quality of life measures as well as preference for ongoing treatment after experience of both products.


RESULTS
The two depot T products had distinct pharmacokinetics and were not bioequivalent. However, there were no consistent clinical differences in a comprehensive range of pharmacodynamic measures reflecting androgen effects on biochemistry and haematology, muscle mass and strength, and quality of life, mood and sexual function. The majority (91%) of participants chose TU over TI at study completion.


CONCLUSIONS
Despite significant pharmacokinetic differences, the two depot T products are clinically interchangeable allowing for choice dependent on patient and physician delivery preference in practice but most patients preferred the injectable over the implantable form.
Fennell
Carolyn
C
Andrology Department, Concord Hospital & ANZAC Research Institute, University of Sydney, Sydney, NSW, Australia.
Sartorius
Gideon
G
Ly
Lam P
LP
Turner
Leo
L
Liu
Peter Y
PY
Conway
Ann J
AJ
Handelsman
David J
DJ
D000728:Androgens / Q000172:deficiency; D018592:Cross-Over Studies; D004343:Drug Implants; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy*; D008297:Male; D017060:Patient Satisfaction; D011788:Quality of Life; D013739:Testosterone / Q000008:administration & dosage* / Q000031:analogs & derivatives / Q000493:pharmacokinetics / Q000627:therapeutic use
D000728:Androgens; D004343:Drug Implants; D013739:Testosterone; C010792:testosterone undecanoate