stop_circleTerminated/Withdrawn

Hypogonadism

Bayer Identifier:

14853

ClinicalTrials.gov Identifier:

NCT01092858

EudraCT Number:

2009-017139-16

EU CT Number:

Not Available
NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

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.

Key Participants Requirements

Sex

Male

Age

60 - N/A
  • - 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

  • - 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

Trial summary

Enrollment Goal
4
Trial Dates
September 2010 - July 2011
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Nebido (Testosterone Undeconate, BAY86-5037)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Uniklinik KölnKöln, 50931, Germany

Primary Outcome

  • Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks
    date_rangeTime Frame:
    At baseline, at week 54
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Isometric maximum strength
    date_rangeTime Frame:
    At baseline, at week 54
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    Safety Issue:
    no
  • Grip strength
    date_rangeTime Frame:
    At baseline, at week 54
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    Safety Issue:
    no
  • Chair raising test
    date_rangeTime Frame:
    At baseline, at week 54
    enhanced_encryption
    Safety Issue:
    no
  • Arm curl test
    date_rangeTime Frame:
    At baseline, at week 54
    enhanced_encryption
    Safety Issue:
    no
  • Bicycle stress test with spirometry
    date_rangeTime Frame:
    At baseline, at week 54
    enhanced_encryption
    Safety Issue:
    no
  • SF-36 Questionnaire
    date_rangeTime Frame:
    At baseline, at week 54
    enhanced_encryption
    Safety Issue:
    no
  • AMS-Questionnaire
    date_rangeTime Frame:
    At baseline, at week 54
    enhanced_encryption
    Safety Issue:
    no
  • FINGER Questionnaire
    date_rangeTime Frame:
    At baseline, at week 54
    enhanced_encryption
    Safety Issue:
    no

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

Additional Information

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