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

• Conditions: The objective of this study is to determine whether in older men with symptomatic age-associated testosterone deficiency exercise training in combination with testosterone replacement therapy leads to improvement of muscle strength, physical function and quality of life more than exercise alone.; MedDRA version: 12.1Level: LLTClassification code 10021011Term: Hypogonadism male

• Registration Number: EUCTR2009-017139-16-DE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-18
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Men aged 60 years and older (>60yrs), untrained
2. Symptomatic hypogonadism as defined by i and iii:
i Total testosterone below 12nmol/l (two tests taken on two different
days, measurement 7.00-11.00 a.m.)
ii Symptoms of testosterone deficiency recorded in the medical history at
screening
and
ii Total Aging Males’ Symptom score above 36
3. Willing to avoid significant change in the pattern of physical exercise and
lifestyle for the duration of the study
4. Residence in Cologne Area
5. Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous assignment to treatment during this study
2.Use of androgen therapy or anabolic steroids within 12 months of
entry into the study (i.e. screening visit/visit 1)
3.Current participation in an exercise program or within the last 6 months
4.Suspicion or known history of prostate or breast cancer or other hormone
dependent neoplasia
5.Abnormal finding on Digital Rectal Examination (DRE)
6.Prostate specific antigen (PSA) level =4ng/ml
7.History of clinically significant post void residual urine (> 150ml)
8.Suspicion or known history of liver tumor
9.Hypersensitivity to the active substances or any of the excipients of
NEBIDO e.g. benzyl-benzoate and castor oil
10.Blood coagulation irregularities presenting an increased risk of bleeding
after intramuscular injections including vitamin-K-antagonists or other
strong anticoagulants
11.Hypercalcemia accompanying malignant tumors
12.Diagnosed sleep apnea
13.Polycythemia
14.Hematocrit level >50% at entry to the study (i.e. screening visit/visit 1)
15.Use of 5-a-reductase inhibitors (finasteride, dutasteride)
16.Prolactin level >25ng/ml
17.Organic hypothalamic-pituitary pathology
18.Concurrent use of: androgens including dehydroepiandrosterone (DHEA),
anabolic steroids, clomipramine, antiandrogens, estrogen, corticotrophins
(ACTH), corticosteroids, oxyphenbutazone, growth hormone
19.Body mass index >35kg/m2
20.Uncontrolled thyroid disorders
21.Uncontrolled diabetes mellitus (HbA1c > 9%)
22.Epilepsy not adequately controlled by treatment
23.Migraine not adequately controlled by treatment
24.Patients requiring or undergoing fertility treatment
25.Any clinically significant chronic disease that might, in the opinion of the
investigator, compromise patient’s safety, interfere with the evaluations,
or preclude completion of the trial (e.g. hemochromatosis, chronic lung
disease, chronic malabsorption disease)
26.Known history of alcohol or drug / substance abuse
27.Any medical, psychiatric or other conditions that compromise the patient’s
ability to understand the patient information, to give informed consent, to
comply with the trial protocol, to understand the questionnaires, to follow
the training instructions or to complete the study (e.g.: illiterate; severe
visual impairment, severe hearing imparment in the opinion of the
investigator).
28.Patients under legal protection
29.Hypertension which is not adequately controlled
30.Heart failure (NYHA II-IV)
31.Severe hepatic or severe renal insufficiency in the opinion of the
investigator
32.Cardiopulmonary disease (Myocardial infarction, angina pectoris),
Coronary heart disease not stabilized by therapy (unstable angina
pectoris, severe cardiac dysrhythmia/arrhythmia), chronic obstructive
pulmonary disease (COPD), history of cerebrovascular accident (transient
ischemic attack [TIA], stroke), neuromuscular impairments or unstable
medical condition that would contraindicate progressive resistance and
endurance exercise training in the opinion of the investigator
33.Concomitant participation in another clinical trial within 1 month of entry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified