44855
document
Efficacy and safety of two different testosterone undecanoate formulations in hypogonadal men with metabolic syndrome . AIM To investigate efficacy and safety of two different preparations of testosterone undecanoate ( TU ) in 52 hypogonadal men [ mean age 57 yr and mean testosterone ( T ) < 320 ng/dl ] with metabolic syndrome ( MS ) . SUBJECTS AND METHODS Randomized , double-blind , double-dummy study with three parallel treatment arms [ oral TU ; transdermal placebo gel ( P ) ; im TU ] administration for 12 months ( mo ) . Each subject was randomized ( 1:1:3 ) to receive either oral TU ( 2 capsules of 40 mg/twice per day at breakfast and dinner , equalling a total dose of 160 mg/day ; no.=10 ) for 6 mo and continued with im TU for further 6 mo , or P ( 3-4 g/day ; no.=10 ) and im TU ( 1000 mg/12 weeks from week 6 ; no.=32 ) for 12 mo . RESULTS After 6 mo , im TU increased T and free- T levels ( p < 0.0001 ) , and improved metabolic parameters [ reduction in Homeostasis Model Assessment ( HOMA ) index , p < 0.0001 ; waist circumference and fat mass , p < 0.001 , respectively ] , in International Index of Erectile Function-5 and Aging Males ' Symptoms scores ( p < 0.01 , respectively ) . After 12 months , im TU produced further increases in T and free- T levels ( p < 0.0001 ) and metabolic parameters ( reduction in HOMA-index , p < 0.0001 ; waist circumference p < 0.0001 ; fat mass , p < 0.001 ) . No major adverse event due to T treatment occurred . CONCLUSIONS Clinical efficacy of T replacement therapy in hypogonadal men with MS is reached when its plasmatic levels approach into the medium-high range of normality ( > 5 ng/ml ) , although subjective threshold values may be different . Administration of im TU was more effective than oral TU to reach the target for T levels and to improve MS parameters . TU was safe over 12 months and discontinuation rates were similar to placebo .
44856
Intervention_Physical
two different testosterone undecanoate formulations
44857
Intervention_Physical
two different preparations of testosterone undecanoate ( TU )
44858
Intervention_Control
transdermal placebo gel
44859
Intervention_Pharmacological
oral TU
44860
Intervention_Control
P
44861
Intervention_Pharmacological
im TU
44862
Intervention_Pharmacological
im TU
44863
Intervention_Pharmacological
TU
44864
Intervention_Control
placebo
44865
Outcome_Physical
T and free- T levels
44866
Outcome_Physical
metabolic parameters
44867
Outcome_Physical
Homeostasis Model Assessment ( HOMA ) index
44868
Outcome_Physical
waist circumference and fat mass
44869
Outcome_Other
International Index of Erectile Function-5 and Aging Males ' Symptoms scores
44870
Outcome_Physical
T and free- T levels
44871
Outcome_Physical
metabolic parameters
44872
Outcome_Other
HOMA-index
44873
Outcome_Physical
waist circumference
44874
Outcome_Physical
fat mass
44875
Outcome_Physical
T levels
44876
Participant_Condition
hypogonadal
44877
Participant_Sex
men
44878
Participant_Condition
metabolic syndrome
44879
Participant_Sample-size
52
44880
Participant_Condition
hypogonadal
44881
Participant_Sex
men
44882
Participant_Age
age
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Participant_Sample-size
57 yr
44884
Participant_Condition
metabolic syndrome ( MS )
44885
Participant_Condition
hypogonadal
44886
Participant_Sex
men
44887
Participant_Condition
MS