Trial Condition(s):
Hypogonadism
NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)
Bayer Identifier:
14853
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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 AreaExclusion 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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Uniklinik Köln Köln, Germany, 50931 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeksTimeframe: At baseline, at week 54
Secondary Outcome
- Isometric maximum strengthTimeframe: At baseline, at week 54
- Grip strengthTimeframe: At baseline, at week 54
- Chair raising testTimeframe: At baseline, at week 54
- Arm curl testTimeframe: At baseline, at week 54
- Bicycle stress test with spirometryTimeframe: At baseline, at week 54
- SF-36 QuestionnaireTimeframe: At baseline, at week 54
- AMS-QuestionnaireTimeframe: At baseline, at week 54
- FINGER QuestionnaireTimeframe: At baseline, at week 54
Additional Information
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