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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypogonadism

Intervention: NEBIDO (Drug); PLACEBO (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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

Clinical Details

Official title: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To assess the change from baseline in lean body mass after 54 weeks of treatment with NEBIDO compared to placebo

Secondary outcome:

Change from baseline in total body mass

Change from baseline in fat mass

Change from baseline in bone mineral density

Aging Male Symptoms (AMS) rating scale

International Index of Erectile Function- erectile function domain (IIEF-EF)

Change in serum levels of testosterone (central laboratory)

Change in waist circumference

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.


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.


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


- Concomitant participation in another clinical trial within 1 month of entry into this

study (i. e. randomized and has taken study medication).

Locations and Contacts

Milano 20132, Italy

Napoli 80131, Italy

Roma 00155, Italy

Riga LV-1002, Latvia

Lodz 91-425, Poland

Warszawa 01-432, Poland

Warszawa 01-809, Poland

Warszawa 02-777, Poland

Wroclaw 50-088, Poland

Moscow 123367, Russian Federation

Moscow 117036, Russian Federation

Novosibirsk 630091, Russian Federation

St. Petersburg 197022, Russian Federation

Volgograd 400138, Russian Federation

Cardiff CF14 5GJ, United Kingdom

Chorley PR7 7NA, United Kingdom

London NW3 2QG, United Kingdom

London NW9 9NH, United Kingdom

Manchester M15 6SX, United Kingdom

Reading, Berkshire RG2 7AG, United Kingdom

Bonn, Nordrhein-Westfalen 53105, Germany

Halle, Sachsen-Anhalt 06097, Germany

Lichfield, Staffordshire WS14 9JL, United Kingdom

Glasgow, Stratchclyde G81 2DR, United Kingdom

Birmingham, West Midlands B15 2SQ, United Kingdom

Additional Information

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Starting date: October 2008
Last updated: November 22, 2012

Page last updated: August 23, 2015

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