Terminated/Withdrawn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

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

Trial summary

Enrollment Goal

Trial Dates

September 2010 - July 2011

Phase

Phase 4

Could I Receive a placebo

Yes

Products

Nebido (Testosterone Undeconate, BAY86-5037)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Uniklinik Köln	Köln, 50931, Germany

Primary Outcome

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

Secondary Outcome

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

Additional Information

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