NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Exercise Alone or in Combination With Testosterone Replacement on Muscle Strength and Quality of Life in Older Men With Low Testosterone Concentrations: a Randomized Double-blind, Placebo Controlled Study

Conditions
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Hypogonadism

Intervention / Treatment
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* Drug: Testosterone Undeconate (Nebido, BAY86-5037)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Testosterone Undeconate (Nebido, BAY86-5037)<br>* 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<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks |  | At baseline, at week 54 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric maximum strength |  | At baseline, at week 54 | 
| Grip strength |  | At baseline, at week 54 | 
| Chair raising test |  | At baseline, at week 54 | 
| Arm curl test |  | At baseline, at week 54 | 
| Bicycle stress test with spirometry |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testosterone undecanoate, Hypogonadism