Hypogonadism
Conditions
Keywords
Testosterone undecanoate, Hypogonadism
Brief summary
The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the steady state of the parameters assessed.
Interventions
DRUGTestosterone Undeconate (Nebido, BAY86-5037)
Testosterone undecanoate 1000 mg (4 ml) i.m. injection at baseline, at week 6, at week 18, at week 30 and at week 42, respectively
DRUGPlacebo
Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men aged 60 years and older (\>60yrs), untrained * Symptomatic hypogonadism as defined by a) and b) * a) Total testosterone below 12 nmol/l (measurement 7.00-11.00 a.m.) * b)Total Aging Males' symptom score above 36 * Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study * Residence in Cologne Area
Exclusion criteria
* Previous assignment to treatment during this study * Use of androgen therapy or anabolic steroids respectively 12 months of entry into the study (i.e. screening visit/visit 1) * Current participation in an exercise program or within the last 6 months * Suspicion or known history of prostate or breast cancer or other hormone dependent neoplasia * Abnormal finding on Digital Rectal Examination (DRE) * Prostate specific antigen (PSA) level \>4 ng/ml * History of clinically significant post void residual urine (\> 150 ml) * Suspicion or known history of liver tumor * Hypersensitivity to the active substances or any of the excipients of NEBIDO e.g. benzyl-benzoate and castor oil * Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections including vitamin-K-antagonists or other strong anticoagulants * 32 Additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks | At baseline, at week 54 |
Secondary
| Measure | Time frame |
|---|---|
| Grip strength | At baseline, at week 54 |
| Chair raising test | At baseline, at week 54 |
| Arm curl test | At baseline, at week 54 |
| Isometric maximum strength | At baseline, at week 54 |
| SF-36 Questionnaire | At baseline, at week 54 |
| AMS-Questionnaire | At baseline, at week 54 |
| FINGER Questionnaire | At baseline, at week 54 |
| Bicycle stress test with spirometry | At baseline, at week 54 |
Countries
Germany
Outcome results
None listed