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

NCT00710827 | Withdrawn Phase 4

• 3 other identifiers: 915792008-002053-20310874
• Study Type: interventional
• Target: N/A
• Locations: 6 countries
• Sites: 25

Brief Summary

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

Conditions

Hypogonadism

Keywords

NEBIDO,; Hypogonadism,; Symptomatic late onset,; Testosterone deficiency

Outcome Measures

Primary Outcomes (1)

• To assess the change from baseline in lean body mass after 54 weeks of treatment with NEBIDO compared to placebo

  Baseline, week 30, week 54

Secondary Outcomes (7)

• Change from baseline in total body mass

  Baseline, week 30, week 54

• Change from baseline in fat mass

  Baseline, week 30, week 54

• Change from baseline in bone mineral density

  Baseline, week 30, week 54

• Aging Male Symptoms (AMS) rating scale

  Baseline, week 30, week 54

• International Index of Erectile Function- erectile function domain (IIEF-EF)

  Baseline, week 30, week 54

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: NEBIDO

Arm 2

PLACEBO COMPARATOR

Drug: PLACEBO

Interventions

NEBIDO DRUG

Patients will receive 54 weeks of treatment with Nebido, 5 intramuscular injections of 4ml Nebido (at baseline, week 6, 18, 30, 42)

Arm 1

PLACEBO DRUG

Patients will receive 54 weeks of treatment with placebo, 5 intramuscular injections of 4ml placebo (at baseline, week 6, 18, 30, 42)

Arm 2

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (25)

Unknown Facility

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Unknown Facility

Halle, Saxony-Anhalt, 06097, Germany

Location

Unknown Facility

Milan, 20132, Italy

Location

Unknown Facility

Napoli, 80131, Italy

Location

Unknown Facility

Roma, 00155, Italy

Location

Unknown Facility

Riga, LV-1002, Latvia

Location

Unknown Facility

Lodz, 91-425, Poland

Location

Unknown Facility

Warsaw, 01-432, Poland

Location

Unknown Facility

Warsaw, 01-809, Poland

Location

Unknown Facility

Warsaw, 02-777, Poland

Location

Unknown Facility

Wroclaw, 50-088, Poland

Location

Unknown Facility

Moscow, 117036, Russia

Location

Unknown Facility

Moscow, 123367, Russia

Location

Unknown Facility

Novosibirsk, 630091, Russia

Location

Unknown Facility

Saint Petersburg, 197022, Russia

Location

Unknown Facility

Volgograd, 400138, Russia

Location

Unknown Facility

Reading, Berkshire, RG2 7AG, United Kingdom

Location

Unknown Facility

London, London, NW3 2QG, United Kingdom

Location

Unknown Facility

London, London, NW9 9NH, United Kingdom

Location

Unknown Facility

Manchester, Manchester, M15 6SX, United Kingdom

Location

Unknown Facility

Lichfield, Staffordshire, WS14 9JL, United Kingdom

Location

Unknown Facility

Glasgow, Stratchclyde, G81 2DR, United Kingdom

Location

Unknown Facility

Birmingham, West Midlands, B15 2SQ, United Kingdom

Location

Unknown Facility

Cardiff, CF14 5GJ, United Kingdom

Location

Unknown Facility

Chorley, PR7 7NA, United Kingdom

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

LA (1); IT (3); DE (2); PL (5); RU (5); GB (9)