TY - JOUR

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 -