NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-07-31

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.

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Detailed Description

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Conditions

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Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Testosterone Undeconate (Nebido, BAY86-5037)

Intervention Type DRUG

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

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively

Interventions

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Testosterone Undeconate (Nebido, BAY86-5037)

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

Intervention Type DRUG

Placebo

Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively

Intervention Type DRUG

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

Minimum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No