Trial Condition(s):
Nebido versus placebo in elderly men with typical symptoms of late onset hypogonadism over a period of 54 weeks
91579
Not Available
To evaluate the safety and efficacy of Nebido compared to placebo in elderly men aged 50 and over with symptomatic late onset hypogonadism
- 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).
Locations | |
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Locations Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg Halle, Germany, 06097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cardiff Clinical Research Centre Cardiff, United Kingdom, CF14 5GJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital of St John and St Elizabeth London, United Kingdom, NW9 9NH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Synexus Limited Birmingham Birmingham, United Kingdom, B15 2SQ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Free Hospital London, United Kingdom, NW3 2QG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Synexus Limited Manchester Manchester, United Kingdom, M15 6SX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Synexus Skandynawskie Centrum Medyczne Wroclaw, Poland, 50-088 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Bielanski im. Ks. Jerzego Popieluszki Warszawa, Poland, 01-809 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Leczenia Chorób Cywilizacyjnych Warszawa, Poland, 02-777 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Endocrinology Scientific Centre Moscow, Russia, 117036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Hospital of Railway Ministry Moscow, Russia, 123367 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Hospital no 25 Volgograd, Russia, 400138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Paula Stradina Kliniskas Universitates slimnica Riga, Latvia, LV-1002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Synexus Limited Reading Reading, United Kingdom, RG2 7AG | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Synexus Limited Glasgow Glasgow, United Kingdom, G81 2DR | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Synexus Lancashire Clinical Research Chorley, United Kingdom, PR7 7NA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Clinic Lichfield, United Kingdom, WS14 9JL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NZOZ Centrum Medyczne Wola Warszawa, Poland, 01-432 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinika Andrologi i Endokrynologii Plodnosci Lodz, Poland, 91-425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Federico II Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Azienda Policlinico Umberto I Roma, Italy, 00155 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations State Medical Academy Novosibirsk, Russia, 630091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Petersburg Medical University n.a. Pavlov St. Petersburg, Russia, 197022 | Contact Us: E-mail: [email protected] Phone: Not Available |
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