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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00710827

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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 ]

Estimated Enrollment:	435
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: NEBIDO Patients will receive 54 weeks of treatment with Nebido, 5 intramuscular injections of 4ml Nebido (at baseline, week 6, 18, 30, 42)
Arm 2: Placebo Comparator	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; hematocrit Measured at screening, week 6, 18, 30, 42, 54, safety measure Adverse events Measured at screening, baseline, week 6, 18, 30, 42, 54 Vital signs Measured 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

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

Show 25 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Therapeutic Area Head )
Study ID Numbers:	91579, 2008-002053-20, 310874
Study First Received:	July 2, 2008
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00710827 History of Changes
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 and Social Development of the Russian Federation; Latvia: State Agency of Medicines

Keywords provided by Bayer:

NEBIDO,
Hypogonadism,
Symptomatic late onset,
Testosterone deficiency

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Testosterone
Anabolic Agents
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on February 08, 2010