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HypogonadismPhase 4NCT00710827

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

A Phase 4 study testing NEBIDO in people with Hypogonadism, run by Bayer at 25 sites in 6 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Hypogonadism
What is being tested?
NEBIDO
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
25 sitesin 6 countries
Study dates
Oct 2008to Oct 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 22Show fewer
  • 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 locations and contacts

25 sites in 6 countries.

25 sites in 6 countries

United Kingdom9 sites

  • Study site

    Birmingham, West Midlands, B15 2SQ

  • Study site

    Cardiff, CF14 5GJ

  • Study site

    Chorley, PR7 7NA

  • Study site

    Glasgow, Stratchclyde, G81 2DR

  • Study site

    Lichfield, Staffordshire, WS14 9JL

  • Study site

    London, London, NW3 2QG

  • Study site

    London, London, NW9 9NH

  • Study site

    Manchester, Manchester, M15 6SX

  • Study site

    Reading, Berkshire, RG2 7AG

Other trials in United Kingdom

Poland5 sites

  • Study site

    Lodz, 91-425

  • Study site

    Warsaw, 01-432

  • Study site

    Warsaw, 01-809

  • Study site

    Warsaw, 02-777

  • Study site

    Wroclaw, 50-088

Other trials in Poland

Russia5 sites

  • Study site

    Moscow, 117036

  • Study site

    Moscow, 123367

  • Study site

    Novosibirsk, 630091

  • Study site

    Saint Petersburg, 197022

  • Study site

    Volgograd, 400138

Other trials in Russia

Italy3 sites

  • Study site

    Milan, 20132

  • Study site

    Naples, 80131

  • Study site

    Roma, 00155

Other trials in Italy

Germany2 sites

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Halle, Saxony-Anhalt, 06097

Other trials in Germany

Latvia1 site

  • Study site

    Riga, LV-1002

Other trials in Latvia

About this study

Official title: 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)

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

Read the detailed description

Explorative objectives: Change in grip strength (Subgroup only: optional for sites with experienced in testing muscle function); Change in physical performance test i.e. lower limb muscle strength (subgroup only; optional for sites experienced in testing muscle function). Please note that the 2 explorative objectives mentioned above must be performed together. All measured at baseline, week 30, week 54, no safety measure. Safety parameters Prostate safety: digital rectal examination (DRE) Measured at screening, week 30+ 54, safety measure. International prostate symptom score (IPSS): International prostate symptom score (IPSS) Measured at screening, week 18, 30, 42, 54, safety measure. Laboratory tests for lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) and liver function tests (aspartate aminotransferase (AST) and alanine transaminase (ALT)) Measured at screening, week 6, 18, 30, 42, 54, safety measure. Standard laboratory tests for androgen treatment: prostate specific antigen (PSA); hemoglobin; hematocritMeasured at screening, week 6, 18, 30, 42, 54, safety measureAdverse eventsMeasured at screening, baseline, week 6, 18, 30, 42, 54Vital signsMeasured at screening, week 18, 30, 42, 54, safety measure.

Conditions
Hypogonadism
Being tested
NEBIDO, PLACEBO
Keywords
NEBIDO,, Hypogonadism,, Symptomatic late onset,, Testosterone deficiency
Medical subject headings
Hypogonadism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEBIDODrug

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

  • PLACEBODrug

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

Study groups in NCT00710827
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: NEBIDO
Arm 2Placebo comparatorNot described
Receives: Drug: PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, week 30, week 54

Secondary outcomes (7)

  1. Change from baseline in total body mass

    Measured: Baseline, week 30, week 54

  2. Change from baseline in fat mass

    Measured: Baseline, week 30, week 54

  3. Change from baseline in bone mineral density

    Measured: Baseline, week 30, week 54

  4. Aging Male Symptoms (AMS) rating scale

    Measured: Baseline, week 30, week 54

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

    Measured: Baseline, week 30, week 54

  6. Change in serum levels of testosterone (central laboratory)

    Measured: Baseline, week 30, week 54

  7. Change in waist circumference

    Measured: Baseline, week 30, week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2008 (estimated)
  2. Study startOct 2008
  3. Study completionOct 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00710827
Sponsor's protocol ID
91579
Other IDs
2008-002053-20, 310874, 2008
Status last verified
Nov 2012
First submitted
2 Jul 2008
Last updated
27 Nov 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing NEBIDO in people with Hypogonadism, run by Bayer at 25 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United Kingdom, Poland, Russia, Italy, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00710827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.

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