Clinical trial NCT01092858: NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypogonadism
Keywords: Testosterone undecanoate
Hypogonadism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 4
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks
timeFrame: At baseline, at week 54
Secondary outcomes:
measure: Isometric maximum strength
timeFrame: At baseline, at week 54
measure: Grip strength
timeFrame: At baseline, at week 54
measure: Chair raising test
timeFrame: At baseline, at week 54
measure: Arm curl test
timeFrame: At baseline, at week 54
measure: Bicycle stress test with spirometry
timeFrame: At baseline, at week 54
measure: SF-36 Questionnaire
timeFrame: At baseline, at week 54
measure: AMS-Questionnaire
timeFrame: At baseline, at week 54
measure: FINGER Questionnaire
timeFrame: At baseline, at week 54
Other outcomes:
Locations:
city: Köln
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: