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

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)

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

Study Overview

• Status: Withdrawn
• Conditions: Hypogonadism
• Intervention / Treatment: Drug: NEBIDO; Drug: PLACEBO

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53105
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06097
• Italy
  • Milano, Italy, 20132
  • Napoli, Italy, 80131
  • Roma, Italy, 00155
• Latvia
  • Riga, Latvia, LV-1002
• Poland
  • Lodz, Poland, 91-425
  • Warszawa, Poland, 01-432
  • Warszawa, Poland, 01-809
  • Warszawa, Poland, 02-777
  • Wroclaw, Poland, 50-088
• Russian Federation
  • Moscow, Russian Federation, 123367
  • Moscow, Russian Federation, 117036
  • Novosibirsk, Russian Federation, 630091
  • St. Petersburg, Russian Federation, 197022
  • Volgograd, Russian Federation, 400138
• United Kingdom
  • Cardiff, United Kingdom, CF14 5GJ
  • Chorley, United Kingdom, PR7 7NA
  • London, United Kingdom, NW3 2QG
  • London, United Kingdom, NW9 9NH
  • Manchester, United Kingdom, M15 6SX
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG2 7AG
  • Staffordshire
    • Lichfield, Staffordshire, United Kingdom, WS14 9JL
  • Stratchclyde
    • Glasgow, Stratchclyde, United Kingdom, G81 2DR
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2SQ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: NEBIDO; Patients will receive 54 weeks of treatment with Nebido, 5 intramuscular injections of 4ml Nebido (at baseline, week 6, 18, 30, 42)
Placebo Comparator: Arm 2	Drug: PLACEBO; Patients will receive 54 weeks of treatment with placebo, 5 intramuscular injections of 4ml placebo (at baseline, week 6, 18, 30, 42)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the change from baseline in lean body mass after 54 weeks of treatment with NEBIDO compared to placebo	Baseline, week 30, week 54

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in total body mass	Baseline, week 30, week 54
Change from baseline in fat mass	Baseline, week 30, week 54
Change from baseline in bone mineral density	Baseline, week 30, week 54
Aging Male Symptoms (AMS) rating scale	Baseline, week 30, week 54
International Index of Erectile Function- erectile function domain (IIEF-EF)	Baseline, week 30, week 54
Change in serum levels of testosterone (central laboratory)	Baseline, week 30, week 54
Change in waist circumference	Baseline, week 30, week 54

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Study Completion (Anticipated): October 1, 2008

Study Registration Dates

• First Submitted: July 2, 2008
• First Submitted That Met QC Criteria: July 3, 2008
• First Posted (Estimate): July 4, 2008

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 22, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: NEBIDO,; Hypogonadism,; Symptomatic late onset,; Testosterone deficiency
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone undecanoate
• Other Study ID Numbers: 91579; 2008-002053-20 (EudraCT Number); 310874 (Other Identifier: company internal)