A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention)
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A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention). / Bandak, Mikkel; Jørgensen, Niels; Juul, Anders; Lauritsen, Jakob; Kreiberg, Michael; Oturai, Peter Sandor; Helge, Jorn Wulff; Daugaard, Gedske.
I: B M C Cancer, Bind 17, 461, 03.07.2017.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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T1 - A randomized double-blind study of testosterone replacement therapy or placebo in testicular cancer survivors with mild Leydig cell insufficiency (Einstein-intervention)
AU - Bandak, Mikkel
AU - Jørgensen, Niels
AU - Juul, Anders
AU - Lauritsen, Jakob
AU - Kreiberg, Michael
AU - Oturai, Peter Sandor
AU - Helge, Jorn Wulff
AU - Daugaard, Gedske
PY - 2017/7/3
Y1 - 2017/7/3
N2 - Background: Elevated serum levels of luteinizing hormone and slightly decreased serum levels of testosterone(mild Leydig cell insufficiency) is a common hormonal disturbance in testicular cancer (TC) survivors. A number ofstudies have shown that low serum levels of testosterone is associated with low grade inflammation and increasedrisk of metabolic syndrome. However, so far, no studies have evaluated whether testosterone substitution improvesmetabolic dysfunction in TC survivors with mild Leydig cell insufficiency.Methods/design: This is a single-center, randomized, double-blind, placebo-controlled study, designed to evaluatethe effect of testosterone replacement therapy in TC survivors with mild Leydig cell insufficiency. Seventy subjectswill be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited foran information meeting where informed consent will be obtained. Afterwards, a 52-weeks treatment period beginsin which study participants will receive a daily dose of transdermal testosterone or placebo. Dose adjustment willbe made three times during the initial 8 weeks of the study to a maximal daily dose of 40 mg of testosterone inthe intervention arm. Evaluation of primary and secondary endpoints will be performed at baseline, 26 weekspost-randomization, at the end of treatment (52 weeks) and 3 months after completion of treatment (week 64).Discussion: This study is the first to investigate the effect of testosterone substitution in testicular cancer survivorswith mild Leydig cell insufficiency. If positive, it may change the clinical handling of testicular cancer survivors withborderline low levels of testosterone.
AB - Background: Elevated serum levels of luteinizing hormone and slightly decreased serum levels of testosterone(mild Leydig cell insufficiency) is a common hormonal disturbance in testicular cancer (TC) survivors. A number ofstudies have shown that low serum levels of testosterone is associated with low grade inflammation and increasedrisk of metabolic syndrome. However, so far, no studies have evaluated whether testosterone substitution improvesmetabolic dysfunction in TC survivors with mild Leydig cell insufficiency.Methods/design: This is a single-center, randomized, double-blind, placebo-controlled study, designed to evaluatethe effect of testosterone replacement therapy in TC survivors with mild Leydig cell insufficiency. Seventy subjectswill be randomized to receive either testosterone replacement therapy or placebo. The subjects will be invited foran information meeting where informed consent will be obtained. Afterwards, a 52-weeks treatment period beginsin which study participants will receive a daily dose of transdermal testosterone or placebo. Dose adjustment willbe made three times during the initial 8 weeks of the study to a maximal daily dose of 40 mg of testosterone inthe intervention arm. Evaluation of primary and secondary endpoints will be performed at baseline, 26 weekspost-randomization, at the end of treatment (52 weeks) and 3 months after completion of treatment (week 64).Discussion: This study is the first to investigate the effect of testosterone substitution in testicular cancer survivorswith mild Leydig cell insufficiency. If positive, it may change the clinical handling of testicular cancer survivors withborderline low levels of testosterone.
KW - Testicular cancer
KW - Mild Leydig cell insufficiency
KW - Testosterone substitution
U2 - 10.1186/s12885-017-3456-5
DO - 10.1186/s12885-017-3456-5
M3 - Journal article
C2 - 28673265
VL - 17
JO - B M C Cancer
JF - B M C Cancer
SN - 1471-2407
M1 - 461
ER -
ID: 183825185