Nebido Versus Placebo in Elderly Men With Typical Symptoms of Late Onset Hypogonadism Over a Period of 54 Weeks

NCT ID: NCT00710827

Last Updated: 2012-11-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2008-10-31

Brief Summary

To evaluate the safety and efficacy of Nebido compared to placebo in elderly men aged 50 and over with symptomatic late onset hypogonadism

Detailed Description

Explorative objectives: Change in grip strength (Subgroup only: optional for sites with experienced in testing muscle function); Change in physical performance test i.e. lower limb muscle strength (subgroup only; optional for sites experienced in testing muscle function). Please note that the 2 explorative objectives mentioned above must be performed together. All measured at baseline, week 30, week 54, no safety measure. Safety parameters Prostate safety: digital rectal examination (DRE) Measured at screening, week 30+ 54, safety measure. International prostate symptom score (IPSS): International prostate symptom score (IPSS) Measured at screening, week 18, 30, 42, 54, safety measure. Laboratory tests for lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) and liver function tests (aspartate aminotransferase (AST) and alanine transaminase (ALT)) Measured at screening, week 6, 18, 30, 42, 54, safety measure. Standard laboratory tests for androgen treatment: prostate specific antigen (PSA); hemoglobin; hematocritMeasured at screening, week 6, 18, 30, 42, 54, safety measureAdverse eventsMeasured at screening, baseline, week 6, 18, 30, 42, 54Vital signsMeasured at screening, week 18, 30, 42, 54, safety measure.

Conditions

Hypogonadism

Keywords

NEBIDO,; Hypogonadism,; Symptomatic late onset,; Testosterone deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

NEBIDO

Intervention Type: DRUG

Patients will receive 54 weeks of treatment with Nebido, 5 intramuscular injections of 4ml Nebido (at baseline, week 6, 18, 30, 42)

Arm 2

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

Patients will receive 54 weeks of treatment with placebo, 5 intramuscular injections of 4ml placebo (at baseline, week 6, 18, 30, 42)

Interventions

NEBIDO

Patients will receive 54 weeks of treatment with Nebido, 5 intramuscular injections of 4ml Nebido (at baseline, week 6, 18, 30, 42)

Intervention Type: DRUG

PLACEBO

Patients will receive 54 weeks of treatment with placebo, 5 intramuscular injections of 4ml placebo (at baseline, week 6, 18, 30, 42)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Use of androgen therapy or anabolic steroids
• Suspicion or known history of liver tumors, prostate or breast cancer
• Hypersensitivity to the active substances or any of the excipients of NEBIDO e.g. Benzyl benzoate and castor oil. Hypercalcemia accompanying malignant tumors
• Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections sleep apnea
• Polycythemia
• Hematocrit level >50% at entry to the study (i.e. screening visit/visit 1)
• Patients using 5-a-reductase inhibitors such as finasteride or dutasteride should be excluded from the study.
• Prolactin level >25ng/ml
• Organic hypothalamic-pituitary pathology
• Prostate specific antigen (PSA) level ≥ 4ng/ml
• Severe symptomatic benign prostatic hyperplasia (IPSS sum score ≥ 20)
• Epilepsy not adequately controlled by treatment
• Migraine not adequately controlled by treatment
• Patients requiring or undergoing fertility treatment
• 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)
• Known history of alcohol or drug abuse
• 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.
• Hypertension which is not adequately controlled on therapy
• Severe cardiac, hepatic or renal insufficiency
• Coronary heart disease not stabilized by therapy as assessed by the investigator
• Metal implants in the body (metal implants in the head will not exclude patients from participation)
• Concomitant participation in another clinical trial within 1 month of entry into this study (i.e. randomized and has taken study medication).

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Healthcare AG

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Bonn, North Rhine-Westphalia, Germany

Halle, Saxony-Anhalt, Germany

Milan, , Italy

Napoli, , Italy

Roma, , Italy

Riga, , Latvia

Lodz, , Poland

Warsaw, , Poland

Warsaw, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Moscow, , Russia

Moscow, , Russia

Novosibirsk, , Russia

Saint Petersburg, , Russia

Volgograd, , Russia

Reading, Berkshire, United Kingdom

London, London, United Kingdom

London, London, United Kingdom

Manchester, Manchester, United Kingdom

Lichfield, Staffordshire, United Kingdom

Glasgow, Stratchclyde, United Kingdom

Birmingham, West Midlands, United Kingdom

Cardiff, , United Kingdom

Chorley, , United Kingdom

Countries

Germany; Italy; Latvia; Poland; Russia; United Kingdom

Other Identifiers

2008-002053-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

310874

Identifier Type: OTHER

Identifier Source: secondary_id

91579

Identifier Type: -

Identifier Source: org_study_id