Trial Condition(s):

Hypogonadism

Nebido versus placebo in elderly men with typical symptoms of late onset hypogonadism over a period of 54 weeks

Bayer Identifier:

91579

ClinicalTrials.gov Identifier:

NCT00710827

EudraCT Number:

2008-002053-20

Terminated/Withdrawn

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

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).

Trial Summary

Enrollment Goal
0
Trial Dates
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Phase
4
Could I receive a placebo?
Yes
Products
Nebido (Testosterone Undeconate, BAY86-5037)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg

Halle, Germany, 06097

Status
Not yet recruiting
 
Locations

Cardiff Clinical Research Centre

Cardiff, United Kingdom, CF14 5GJ

Status
Not yet recruiting
 
Locations

Hospital of St John and St Elizabeth

London, United Kingdom, NW9 9NH

Status
Not yet recruiting
 
Locations

Synexus Limited Birmingham

Birmingham, United Kingdom, B15 2SQ

Status
Not yet recruiting
 
Locations

Royal Free Hospital

London, United Kingdom, NW3 2QG

Status
Not yet recruiting
 
Locations

Synexus Limited Manchester

Manchester, United Kingdom, M15 6SX

Status
Not yet recruiting
 
Locations

Synexus Skandynawskie Centrum Medyczne

Wroclaw, Poland, 50-088

Status
Not yet recruiting
 
Locations

Szpital Bielanski im. Ks. Jerzego Popieluszki

Warszawa, Poland, 01-809

Status
Not yet recruiting
 
Locations

Centrum Leczenia Chorób Cywilizacyjnych

Warszawa, Poland, 02-777

Status
Not yet recruiting
 
Locations

Endocrinology Scientific Centre

Moscow, Russia, 117036

Status
Not yet recruiting
 
Locations

Central Hospital of Railway Ministry

Moscow, Russia, 123367

Status
Not yet recruiting
 
Locations

City Hospital no 25

Volgograd, Russia, 400138

Status
Not yet recruiting
 
Locations

Paula Stradina Kliniskas Universitates slimnica

Riga, Latvia, LV-1002

Status
Not yet recruiting
 
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

Status
Not yet recruiting
 
Locations

Synexus Limited Reading

Reading, United Kingdom, RG2 7AG

Status
Not yet recruiting
 
Locations

Synexus Limited Glasgow

Glasgow, United Kingdom, G81 2DR

Status
Not yet recruiting
 
Locations

Synexus Lancashire Clinical Research

Chorley, United Kingdom, PR7 7NA

Status
Not yet recruiting
 
Locations

The Clinic

Lichfield, United Kingdom, WS14 9JL

Status
Not yet recruiting
 
Locations

NZOZ Centrum Medyczne Wola

Warszawa, Poland, 01-432

Status
Not yet recruiting
 
Locations

Klinika Andrologi i Endokrynologii Plodnosci

Lodz, Poland, 91-425

Status
Not yet recruiting
 
Locations

A.O.U. Federico II

Napoli, Italy, 80131

Status
Not yet recruiting
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Not yet recruiting
 
Locations

Azienda Policlinico Umberto I

Roma, Italy, 00155

Status
Not yet recruiting
 
Locations

State Medical Academy

Novosibirsk, Russia, 630091

Status
Not yet recruiting
 
Locations

St. Petersburg Medical University n.a. Pavlov

St. Petersburg, Russia, 197022

Status
Not yet recruiting
 

Trial Design