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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00710827
First received: July 2, 2008
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Hypogonadism
Drug: NEBIDO
Drug: PLACEBO
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in total body mass [ Time Frame: Baseline, week 30, week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in fat mass [ Time Frame: Baseline, week 30, week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in bone mineral density [ Time Frame: Baseline, week 30, week 54 ] [ Designated as safety issue: No ]
  • Aging Male Symptoms (AMS) rating scale [ Time Frame: Baseline, week 30, week 54 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function- erectile function domain (IIEF-EF) [ Time Frame: Baseline, week 30, week 54 ] [ Designated as safety issue: No ]
  • Change in serum levels of testosterone (central laboratory) [ Time Frame: Baseline, week 30, week 54 ] [ Designated as safety issue: No ]
  • Change in waist circumference [ Time Frame: Baseline, week 30, week 54 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2008
Estimated Study Completion Date: October 2008
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710827

Locations
Germany
Bonn, Nordrhein-Westfalen, Germany, 53105
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, 01-809
Warszawa, Poland, 02-777
Warszawa, Poland, 01-432
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00710827     History of Changes
Other Study ID Numbers: 91579, 2008-002053-20, 310874
Study First Received: July 2, 2008
Last Updated: November 22, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Latvia: State Agency of Medicines

Keywords provided by Bayer:
NEBIDO,
Hypogonadism,
Symptomatic late onset,
Testosterone deficiency

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Methyltestosterone
Testosterone 17 beta-cypionate
Testosterone
Testosterone enanthate
Testosterone undecanoate
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgens

ClinicalTrials.gov processed this record on August 28, 2014