A 54 week treatment, randomized, multi center, double blind, placebo controlled study to assess the safety and efficacy of NEBIDO 1000 mg (4 ml) in elderly men with symptomatic late onset hypogonadism (SLOH) - NEBIDO in SLOH

• Conditions: Symptomatic late onset hypogonadism; MedDRA version: 9.1Level: LLTClassification code 10021011Term: Hypogonadism male

• Registration Number: EUCTR2008-002053-20-LV
• Lead Sponsor: Bayer Healthcare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 435

Inclusion Criteria

1.Men aged 50 and older
2.Symptomatic hypogonadism as defined by i and ii:
i.Total testosterone below 12nmol/l
ii.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.Willing to voluntarily sign a statement of informed consent to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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.Use of androgen therapy or anabolic steroids within 12 months of entry into the study (i.e. screening visit/visit 1)
2.Suspicion or known history of prostate or breast cancer
3.Suspicion or known history of liver tumors
4.Hypersensitivity to the active substances or any of the excipients of NEBIDO e.g. Benzyl benzoate and castor oil. Hypercalcemia accompanying malignant tumors
5.Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections
6.Diagnosed sleep apnea
7.Polycythemia
8.Hematocrit level >50% at entry to the study (i.e. screening visit/visit 1)
9.Patients using 5-a-reductase inhibitors such as finasteride or dutasteride should be excluded from the study.
10.Prolactin level >25ng/ml
11.Organic hypothalamic-pituitary pathology
12.Severe psychiatric disease
13.Prostate specific antigen (PSA) level =4ng/ml
14.Severe symptomatic benign prostatic hyperplasia (IPSS sum score =20)
15.Concurrent use of androgens including dehydroepiandrosterone (DHEA), anabolic steroids, clomipramine, antiandrogens, estrogen, cytochrome P450 inducing medicines (e.g. quinidine, ketoconazole, macrolides), corticotrophins (ACTH) and oxyphenbutazone
16.Body mass index >35kg/m2
17.Uncontrolled thyroid disorders
18.Diabetes mellitus with vascular changes or which is uncontrolled
19.Epilepsy not adequately controlled by treatment
20.Migraine not adequately controlled by treatment
21.Patients requiring or undergoing fertility treatment
22.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)
23.Known history of alcohol or drug abuse
24.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, or to complete the study.
25.Hypertension which is not adequately controlled on therapy
26.Severe cardiac, hepatic or renal insufficiency
27.Coronary heart disease not stabilized by therapy as assessed by the investigator
28.Metal implants in the body (metal implants in the head will not exclude patients from participation)
29.Concomitant participation in another clinical trial within 1 month of entry into this study (i.e. randomized and has taken study medication).

Study & Design

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