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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00710827
Recruitment Status : Withdrawn
First Posted : July 4, 2008
Last Update Posted : November 27, 2012
Information provided by:

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

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: NEBIDO Drug: PLACEBO Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2008
Estimated Study Completion Date : October 2008

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)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change from baseline in total body mass [ Time Frame: Baseline, week 30, week 54 ]
  2. Change from baseline in fat mass [ Time Frame: Baseline, week 30, week 54 ]
  3. Change from baseline in bone mineral density [ Time Frame: Baseline, week 30, week 54 ]
  4. Aging Male Symptoms (AMS) rating scale [ Time Frame: Baseline, week 30, week 54 ]
  5. International Index of Erectile Function- erectile function domain (IIEF-EF) [ Time Frame: Baseline, week 30, week 54 ]
  6. Change in serum levels of testosterone (central laboratory) [ Time Frame: Baseline, week 30, week 54 ]
  7. Change in waist circumference [ Time Frame: Baseline, week 30, week 54 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00710827

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Bonn, Nordrhein-Westfalen, Germany, 53105
Halle, Sachsen-Anhalt, Germany, 06097
Milano, Italy, 20132
Napoli, Italy, 80131
Roma, Italy, 00155
Riga, Latvia, LV-1002
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, 117036
Moscow, Russian Federation, 123367
Novosibirsk, Russian Federation, 630091
St. Petersburg, Russian Federation, 197022
Volgograd, Russian Federation, 400138
United Kingdom
Reading, Berkshire, United Kingdom, RG2 7AG
Lichfield, Staffordshire, United Kingdom, WS14 9JL
Glasgow, Stratchclyde, United Kingdom, G81 2DR
Birmingham, West Midlands, United Kingdom, B15 2SQ
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
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Therapeutic Area Head, Bayer Healthcare AG Identifier: NCT00710827    
Other Study ID Numbers: 91579
2008-002053-20 ( EudraCT Number )
310874 ( Other Identifier: company internal )
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012
Keywords provided by Bayer:
Symptomatic late onset,
Testosterone deficiency
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents