Terminated/Withdrawn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

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

Trial Dates

October 2008 - October 2008

Phase

Phase 4

Could I Receive a placebo

Products

Nebido (Testosterone Undeconate, BAY86-5037)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Not yet recruiting	Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg	Halle, 06097, Germany
Not yet recruiting	Cardiff Clinical Research Centre	Cardiff, CF14 5GJ, United Kingdom
Not yet recruiting	Hospital of St John and St Elizabeth	London, NW9 9NH, United Kingdom
Not yet recruiting	Synexus Limited Birmingham	Birmingham, B15 2SQ, United Kingdom
Not yet recruiting	Royal Free Hospital	London, NW3 2QG, United Kingdom
Not yet recruiting	Synexus Limited Manchester	Manchester, M15 6SX, United Kingdom
Not yet recruiting	Synexus Skandynawskie Centrum Medyczne	Wroclaw, 50-088, Poland
Not yet recruiting	Szpital Bielanski im. Ks. Jerzego Popieluszki	Warszawa, 01-809, Poland
Not yet recruiting	Centrum Leczenia Chorób Cywilizacyjnych	Warszawa, 02-777, Poland
Not yet recruiting	Endocrinology Scientific Centre	Moscow, 117036, Russia
Not yet recruiting	Central Hospital of Railway Ministry	Moscow, 123367, Russia
Not yet recruiting	City Hospital no 25	Volgograd, 400138, Russia
Not yet recruiting	Paula Stradina Kliniskas Universitates slimnica	Riga, LV-1002, Latvia
Not yet recruiting	Medizinische Einrichtungen der Universität Bonn	Bonn, 53105, Germany
Not yet recruiting	Synexus Limited Reading	Reading, RG2 7AG, United Kingdom
Not yet recruiting	Synexus Limited Glasgow	Glasgow, G81 2DR, United Kingdom
Not yet recruiting	Synexus Lancashire Clinical Research	Chorley, PR7 7NA, United Kingdom
Not yet recruiting	The Clinic	Lichfield, WS14 9JL, United Kingdom
Not yet recruiting	NZOZ Centrum Medyczne Wola	Warszawa, 01-432, Poland
Not yet recruiting	Klinika Andrologi i Endokrynologii Plodnosci	Lodz, 91-425, Poland
Not yet recruiting	A.O.U. Federico II	Napoli, 80131, Italy
Not yet recruiting	IRCCS Fondazione San Raffaele	Milano, 20132, Italy
Not yet recruiting	Azienda Policlinico Umberto I	Roma, 00155, Italy
Not yet recruiting	State Medical Academy	Novosibirsk, 630091, Russia
Not yet recruiting	St. Petersburg Medical University n.a. Pavlov	St. 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
Time Frame:
Baseline, week 30, week 54
Safety Issue:
no

Secondary Outcome

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

Additional Information

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