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

November 22, 2012 updated by: Bayer

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To assess the change from baseline in lean body mass after 54 weeks of treatment with NEBIDO compared to placebo
Time Frame: Baseline, week 30, week 54
Baseline, week 30, week 54

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in total body mass
Time Frame: Baseline, week 30, week 54
Baseline, week 30, week 54
Change from baseline in fat mass
Time Frame: Baseline, week 30, week 54
Baseline, week 30, week 54
Change from baseline in bone mineral density
Time Frame: Baseline, week 30, week 54
Baseline, week 30, week 54
Aging Male Symptoms (AMS) rating scale
Time Frame: Baseline, week 30, week 54
Baseline, week 30, week 54
International Index of Erectile Function- erectile function domain (IIEF-EF)
Time Frame: Baseline, week 30, week 54
Baseline, week 30, week 54
Change in serum levels of testosterone (central laboratory)
Time Frame: Baseline, week 30, week 54
Baseline, week 30, week 54
Change in waist circumference
Time Frame: Baseline, week 30, week 54
Baseline, week 30, week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 91579
  • 2008-002053-20 (EudraCT Number)
  • 310874 (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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