stop_circleTerminated/Withdrawn

Hypogonadism

Bayer Identifier:

91579

ClinicalTrials.gov Identifier:

NCT00710827

EudraCT Number:

2008-002053-20

EU CT Number:

Not Available
Nebido versus placebo in elderly men with typical symptoms of late onset hypogonadism over a period of 54 weeks

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

50 Years
  • - 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.
  • - 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).

Trial summary

Enrollment Goal
0
Trial Dates
October 2008 - October 2008
Phase
Phase 4
Could I Receive a placebo
No
Products
Nebido (Testosterone Undeconate, BAY86-5037)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Med. Fakultät der Martin-Luther-Universität Halle-WittenbergHalle, 06097, Germany
Not yet recruiting
Cardiff Clinical Research CentreCardiff, CF14 5GJ, United Kingdom
Not yet recruiting
Hospital of St John and St ElizabethLondon, NW9 9NH, United Kingdom
Not yet recruiting
Synexus Limited BirminghamBirmingham, B15 2SQ, United Kingdom
Not yet recruiting
Royal Free HospitalLondon, NW3 2QG, United Kingdom
Not yet recruiting
Synexus Limited ManchesterManchester, M15 6SX, United Kingdom
Not yet recruiting
Synexus Skandynawskie Centrum MedyczneWroclaw, 50-088, Poland
Not yet recruiting
Szpital Bielanski im. Ks. Jerzego PopieluszkiWarszawa, 01-809, Poland
Not yet recruiting
Centrum Leczenia Chorób CywilizacyjnychWarszawa, 02-777, Poland
Not yet recruiting
Endocrinology Scientific CentreMoscow, 117036, Russia
Not yet recruiting
Central Hospital of Railway MinistryMoscow, 123367, Russia
Not yet recruiting
City Hospital no 25Volgograd, 400138, Russia
Not yet recruiting
Paula Stradina Kliniskas Universitates slimnicaRiga, LV-1002, Latvia
Not yet recruiting
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Not yet recruiting
Synexus Limited ReadingReading, RG2 7AG, United Kingdom
Not yet recruiting
Synexus Limited GlasgowGlasgow, G81 2DR, United Kingdom
Not yet recruiting
Synexus Lancashire Clinical ResearchChorley, PR7 7NA, United Kingdom
Not yet recruiting
The ClinicLichfield, WS14 9JL, United Kingdom
Not yet recruiting
NZOZ Centrum Medyczne WolaWarszawa, 01-432, Poland
Not yet recruiting
Klinika Andrologi i Endokrynologii PlodnosciLodz, 91-425, Poland
Not yet recruiting
A.O.U. Federico IINapoli, 80131, Italy
Not yet recruiting
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Not yet recruiting
Azienda Policlinico Umberto IRoma, 00155, Italy
Not yet recruiting
State Medical AcademyNovosibirsk, 630091, Russia
Not yet recruiting
St. Petersburg Medical University n.a. PavlovSt. Petersburg, 197022, Russia

Primary Outcome

  • To assess the change from baseline in lean body mass after 54 weeks of treatment with NEBIDO compared to placebo
    date_rangeTime Frame:
    Baseline, week 30, week 54
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Change from baseline in total body mass
    date_rangeTime Frame:
    Baseline, week 30, week 54
    enhanced_encryption
    Safety Issue:
    no
  • Change from baseline in fat mass
    date_rangeTime Frame:
    Baseline, week 30, week 54
    enhanced_encryption
    Safety Issue:
    no
  • Change from baseline in bone mineral density
    date_rangeTime Frame:
    Baseline, week 30, week 54
    enhanced_encryption
    Safety Issue:
    no
  • Aging Male Symptoms (AMS) rating scale
    date_rangeTime Frame:
    Baseline, week 30, week 54
    enhanced_encryption
    Safety Issue:
    no
  • International Index of Erectile Function- erectile function domain (IIEF-EF)
    date_rangeTime Frame:
    Baseline, week 30, week 54
    enhanced_encryption
    Safety Issue:
    no
  • Change in serum levels of testosterone (central laboratory)
    date_rangeTime Frame:
    Baseline, week 30, week 54
    enhanced_encryption
    Safety Issue:
    no
  • Change in waist circumference
    date_rangeTime Frame:
    Baseline, week 30, week 54
    enhanced_encryption
    Safety Issue:
    no

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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