The objective of this study is to determine whether in older men with symptomatic age-associated testosterone deficiency exercise training in combination with testosterone replacement therapy leads to improvement of muscle strength, physical function and quality of life more than exercise alone. MedDRA version: 12.1 Level: LLT Classification code 10021011 Term: Hypogonadism male
Conditions
Interventions
Trade Name: Nebido 1000 mg Injektionslösung
Product Name: Nebido
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Testosterone undecanoate
CAS Number: 5949-44-0
Other descriptive name:
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men aged 60 years and older (>60yrs), untrained 2. Symptomatic hypogonadism as defined by i and iii: i Total testosterone below 12nmol/l (two tests taken on two different days, measurement 7.00-11.00 a.m.) ii Symptoms of testosterone deficiency recorded in the medical history at screening and ii Total Aging Males’ Symptom score above 36 3. Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study 4. Residence in Cologne Area 5. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous assignment to treatment during this study 2. Use of androgen therapy or anabolic steroids within 12 months of entry into the study (i.e. screening visit/visit 1) 3. Current participation in an exercise program or within the last 6 months 4. Suspicion or known history of prostate or breast cancer or other hormone dependent neoplasia 5. Abnormal finding on Digital Rectal Examination (DRE) 6. Prostate specific antigen (PSA) level =4ng/ml 7. History of clinically significant post void residual urine (> 150ml) 8. Suspicion or known history of liver tumor 9. Hypersensitivity to the active substances or any of the excipients of NEBIDO e.g. benzyl-benzoate and castor oil 10. Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections including vitamin-K-antagonists or other strong anticoagulants 11. Hypercalcemia accompanying malignant tumors 12. Diagnosed sleep apnea 13. Polycythemia 14. Hematocrit level >50% at entry to the study (i.e. screening visit/visit 1) 15. Use of 5-a-reductase inhibitors (finasteride, dutasteride) 16. Prolactin level >25ng/ml 17. Organic hypothalamic-pituitary pathology 18. Concurrent use of: androgens including dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, corticotrophins (ACTH), corticosteroids, oxyphenbutazone, growth hormone 19. Body mass index >35kg/m2 20. Uncontrolled thyroid disorders 21. Uncontrolled diabetes mellitus (HbA1c > 9%) 22. Epilepsy not adequately controlled by treatment 23. Migraine not adequately controlled by treatment 24. Patients requiring or undergoing fertility treatment 25. Any clinically significant chronic disease that might, in the opinion of the investigator, compromise patient’s safety, interfere with the evaluations, or preclude completion of the trial (e.g. hemochromatosis, chronic lung disease, chronic malabsorption disease) 26. Known history of alcohol or drug / substance abuse 27. Any medical, psychiatric or other conditions that compromise the patient’s ability to understand the patient information, to give informed consent, to comply with the trial protocol, to understand the questionnaires, to follow the training instructions or to complete the study (e.g.: illiterate; severe visual impairment, severe hearing imparment in the opinion of the investigator). 28. Patients under legal protection 29. Hypertension which is not adequately controlled 30. Heart failure (NYHA II-IV) 31. Severe hepatic or severe renal insufficiency in the opinion of the investigator 32. Cardiopulmonary disease (Myocardial infarction, angina pectoris), Coronary heart disease not stabilized by therapy (unstable angina pectoris, severe cardiac dysrhythmia/arrhythmia), chronic obstructive pulmonary disease (COPD), history of cerebrovascular accident (transient ischemic attack [TIA], stroke), neuromuscular impairments or unstable medical condition that would contraindicate progressive resistance and endurance exercise training in the opinion of the investigator 33. Concomitant participation in another clinical trial within 1 month of entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Additional effect of TRT in hypogonadal men on dynamic maximum strength (one repetition maximum, 1-RM) of upper and lower extremity;Secondary Objective: Effect of TRT in hypogonadal men on further muscle parameters, endurance, cardiovascular parameters and Quality of Life (QoL);Primary end point(s): Additional effect of testosterone replacement therapy in hypogonadal men on dynamic maximum strength (one repetition maximum - 1-RM - of upper and lower extremety) | — |
Countries
Germany
Outcome results
None listed