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.
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)
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- 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
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
Russia5 sites
Study site
Moscow, 117036
Study site
Moscow, 123367
Study site
Novosibirsk, 630091
Study site
Saint Petersburg, 197022
Study site
Volgograd, 400138
Italy3 sites
Study site
Milan, 20132
Study site
Naples, 80131
Study site
Roma, 00155
Germany2 sites
Study site
Bonn, North Rhine-Westphalia, 53105
Study site
Halle, Saxony-Anhalt, 06097
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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: NEBIDO |
| Arm 2 | Placebo comparator | Not described Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Change from baseline in total body mass
Measured: Baseline, week 30, week 54
Change from baseline in fat mass
Measured: Baseline, week 30, week 54
Change from baseline in bone mineral density
Measured: Baseline, week 30, week 54
Aging Male Symptoms (AMS) rating scale
Measured: Baseline, week 30, week 54
International Index of Erectile Function- erectile function domain (IIEF-EF)
Measured: Baseline, week 30, week 54
Change in serum levels of testosterone (central laboratory)
Measured: Baseline, week 30, week 54
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.
- First posted4 Jul 2008 (estimated)
- Study startOct 2008
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00710827
- Acronym / sponsor ID
- 91579
- Conditions
- Hypogonadism
- Keywords
- NEBIDO,, Hypogonadism,, Symptomatic late onset,, Testosterone deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Study completion
- Oct 2008 (estimated)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of Nebido compared to placebo in elderly men aged 50 and over with symptomatic late onset hypogonadism
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: NEBIDO |
| Arm 2 | Placebo comparator | Drug: PLACEBO |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEBIDOPatients will receive 54 weeks of treatment with Nebido, 5 intramuscular injections of 4ml Nebido (at baseline, week 6, 18, 30, 42) | Drug | Arm 1 |
| PLACEBOPatients will receive 54 weeks of treatment with placebo, 5 intramuscular injections of 4ml placebo (at baseline, week 6, 18, 30, 42) | Drug | Arm 2 |
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
7 secondary outcomes
Change from baseline in total body mass
Time frame: Baseline, week 30, week 54
Change from baseline in fat mass
Time frame: Baseline, week 30, week 54
Change from baseline in bone mineral density
Time frame: Baseline, week 30, week 54
Aging Male Symptoms (AMS) rating scale
Time frame: Baseline, week 30, week 54
International Index of Erectile Function- erectile function domain (IIEF-EF)
Time frame: Baseline, week 30, week 54
Change in serum levels of testosterone (central laboratory)
Time frame: Baseline, week 30, week 54
Change in waist circumference
Time frame: Baseline, week 30, week 54
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
25 sites in 6 countries: see every site and its status.
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?
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.