Male patients with hypogonadism
Conditions
Interventions
Trade Name: NEBIDO
Pharmaceutical Form: Solution for injection
Other descriptive name: TESTOSTERONE UNDECANOATE
Pharmaceutical form of the placebo: Solu
Sponsors
Charalampos Vlachopoulos
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Providing written consent prior to effecting any procedure of the study 2)Male patients 35-64 years 3) Diagnosis of hypogonadism. The deficiency of testosterone should be demonstrated by clinical features, as assessed by medical history, clinical examination and ADAM questionnaire (Annex B) and confirmed by two separate measurements of morning blood testosterone [either total testosterone =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Participation in the design and conduct of the study 2) Participation in another study in the period between the time of the baseline measurement and evaluation which will take place during the observation period, except for participation in registries or epidemiological studies (surveys) that do not affect hypogonadism therapy 3) Female sex 4) Patients > 64 years old or patients = 4 ng / ml 10) Severe symptoms of lower urinary tract due to benign prostatic hyperplasia 11) Malignancy, autoimmune disease or any other modern illness (eg, neurological or psychiatric illness), which could affect or prevent the study to be completed according to the researcher's view 12) Polycythemia / or hematocrit > 50% 13) Overt endocrine disease e.g. uncontrolled thyroid disorders or disorders of the hypothalamic-pituitary adrenal axis (except diabetes mellitus) 14) Contemporary or recent (last year) use of steroids (anabolic or androgenic), ACTH, 5-alpha reductase inhibitors, 5-phosphodiesterase inhibitors, beta-blockers and drugs that are known to affect the testosterone metabolism 15) Severe renal impairment (GFR < 30 ml / min / 1.73m2) 16) Severe hepatic impairment, defined as liver cirrhosis, increased transaminases (AST or ALT) or alkaline phosphatase more than three times the upper normal limit or hyperbilirubinemia 17) Severe obstructive sleep apnea 18) Infertility or desire for immediate procreation (within 2 years of study entry) 19) Simultaneous use of oral vitamin K antagonists (acenocoumarol, warfarin) 20) Patients with restrictions on the use of intramuscular injections as in patients with acquired or congenital abnormalities of blood coagulation 21) Life expectancy less than 3 years 22) Incompliance with the study protocol e.g. due to scheduled move away from the place of the study or abuse of alcohol or drug use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Evaluation of the difference of the mean value of pulsive wave velocity-PWV between the 2 treatment arms ;Timepoint(s) of evaluation of this end point: From baseline until 44 weeks ;Main Objective: Main objective of the study is to determine the effect of long-acting testosterone undecanoate therapy on arterial stiffness and endothelial function and to evaluate the cardiovascular safety of the use of the testosterone undecanoate therapy. Furthermore to evaluate the difference of the mean value of the pulsive wave velocity-PWV between the 2 treatment arms from baseline (time 0) to 44 weeks after the initial administration of the treatment with testosterone or placebo;Secondary Objective: 1) Evaluation of the difference of the mean value of the PWV between the 2 treatment arms 2) Evaluation of the difference of the mean value of the augmentation index-Alx between the 2 treatment arms from baseline to 18,24,30,44 weeks 3) Evaluation of the difference of the mean value of the central (aortic)pulses between the 2 treatment arms from baseline to 18,24,30,44 weeks 4) Evaluation of the difference of the mean value of the flow-mediated dilatation-FMD between the 2 treatment arms from baseline to 18,24,30,44 weeks 5) Evaluation of the difference of the mean value of BMI and ratio of perimeter buttocks between the 2 treatment arms from baseline to 6,18,24,30,42,44 weeks 6) Evaluation of the difference of the mean value of biochemical parameters and inflammation markers between the 2 treatment arms from baseline to 24 and 44 weeks 7) Evaluation of the difference of the mean value of PSA and haematocrit between the 2 treatment arms from baseline to 24,44 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ) Evaluation of the difference of the mean value of the PWV between the 2 treatment arms 2) Evaluation of the difference of the mean value of the augmentation index-AIx between the 2 treatment arms 3) Evaluation of the difference of the mean value to the central aortal pulses (systolic, diastolic, pulse pressure)between the 2 treatment arms 4) Evaluation of the difference of the mean value of flow-mediated dilatation-FMD between the 2 treatment arms 5) Evaluation of the difference of the mean value of BMI and ratio of perimeter buttocks between the 2 treatment arms 6 ) Evaluation of the difference of the mean value of biochemichal parameters and inflammation markers between the 2 treatment arms 7) Evaluation of the difference of the mean value of PSA in blood and haematocrit between the 2 treatment arms ;Timepoint(s) of evaluation of this end point: 1) From baseline (time 0) to 18,24,30 and 44 weeks 2) From baseline (time 0) to 18,24,30 and 44 weeks 3) From baseline (time 0) to 18,24,30 and 44 weeks 4) From baseline (time 0) to 18,24,30 and 44 weeks 5) From baseline (time 0) to 6,18,24,30,42 and 44 weeks 6) From baseline (time 0) to 24 and 44 weeks 7 ) From baseline (time 0) to 24 and 44 weeks | — |
Countries
Greece
Contacts
Public ContactMaria Grammatikou
Hellenic Cardiovascular Research Society
Outcome results
None listed