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Randomized cross‐over clinical trial of injectable vs. implantable depot testosterone for maintenance of testosterone replacement therapy in androgen deficient men
Author(s) -
Fennell Carolyn,
Sartorius Gideon,
Ly Lam P.,
Turner Leo,
Liu Peter Y.,
Conway Ann J.,
Handelsman David J.
Publication year - 2010
Publication title -
clinical endocrinology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.055
H-Index - 147
eISSN - 1365-2265
pISSN - 0300-0664
DOI - 10.1111/j.1365-2265.2009.03744.x
Subject(s) - testosterone (patch) , androgen , medicine , androgen deficiency , pharmacokinetics , pharmacodynamics , randomized controlled trial , depot , bioequivalence , randomization , testosterone replacement , hormone replacement therapy (female to male) , endocrinology , urology , hormone , archaeology , history
Summary 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. Design, setting and participants 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. Outcomes 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. Conclusion 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.