HypogonadismPhase 4NCT01092858
NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)
A Phase 4 study testing Testosterone Undeconate (Nebido, BAY86-5037) in people with Hypogonadism, run by Bayer at 1 site in Germany.
Trial summary
The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone… Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosterone Undeconate (Nebido, BAY86-5037)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Jul 2011
- 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 60 years and older (>60yrs), untrained
- Symptomatic hypogonadism as defined by a) and b)
- a) Total testosterone below 12 nmol/l (measurement 7.00-11.00 a.m.)
- b)Total 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
- Residence in Cologne Area
Who cannot join
- Previous assignment to treatment during this study
- Use of androgen therapy or anabolic steroids respectively 12 months of entry into the study (i.e. screening visit/visit 1)
- Current participation in an exercise program or within the last 6 months
- Suspicion or known history of prostate or breast cancer or other hormone dependent neoplasia
- Abnormal finding on Digital Rectal Examination (DRE)
- Prostate specific antigen (PSA) level >4 ng/ml
Show all 11Show fewer
- History of clinically significant post void residual urine (> 150 ml)
- Suspicion or known history of liver tumor
- Hypersensitivity to the active substances or any of the excipients of NEBIDO e.g. benzyl-benzoate and castor oil
- Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections including vitamin-K-antagonists or other strong anticoagulants
- 32 Additional Exclusion Criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise Alone or in Combination With Testosterone Replacement on Muscle Strength and Quality of Life in Older Men With Low Testosterone Concentrations: a Randomized Double-blind, Placebo Controlled Study
The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the "steady state" of the parameters assessed.
- Conditions
- Hypogonadism
- Being tested
- Testosterone Undeconate (Nebido, BAY86-5037), Placebo
- Keywords
- Testosterone undecanoate, Hypogonadism
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Undeconate (Nebido, BAY86-5037)Drug
Testosterone undecanoate 1000 mg (4 ml) i.m. injection at baseline, at week 6, at week 18, at week 30 and at week 42, respectively
PlaceboDrug
Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Testosterone Undeconate (Nebido, BAY86-5037) |
| 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.
Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks
Measured: At baseline, at week 54
Secondary outcomes (8)
Isometric maximum strength
Measured: At baseline, at week 54
Grip strength
Measured: At baseline, at week 54
Chair raising test
Measured: At baseline, at week 54
Arm curl test
Measured: At baseline, at week 54
Bicycle stress test with spirometry
Measured: At baseline, at week 54
SF-36 Questionnaire
Measured: At baseline, at week 54
AMS-Questionnaire
Measured: At baseline, at week 54
FINGER Questionnaire
Measured: At baseline, at week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionJul 2011
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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092858
- Sponsor's protocol ID
- 14853
- Other IDs
- 2009-017139-16, 2009
- Status last verified
- Nov 2014
- First submitted
- 24 Mar 2010
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Alone or in Combination With Testosterone Replacement on Muscle Strength and Quality of Life in Older Men With Low Testosterone Concentrations: a Randomized Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01092858
- Acronym / sponsor ID
- 14853
- Conditions
- Hypogonadism
- Keywords
- Testosterone undecanoate, Hypogonadism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Mar 2010 (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.
The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the "steady state" of the parameters assessed.
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: Testosterone Undeconate (Nebido, BAY86-5037) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men aged 60 years and older (>60yrs), untrained
- Symptomatic hypogonadism as defined by a) and b)
- a) Total testosterone below 12 nmol/l (measurement 7.00-11.00 a.m.)
- b)Total 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 (11 listed)
- Previous assignment to treatment during this study
- Use of androgen therapy or anabolic steroids respectively 12 months of entry into the study (i.e. screening visit/visit 1)
- Current participation in an exercise program or within the last 6 months
- Suspicion or known history of prostate or breast cancer or other hormone dependent neoplasia
- Abnormal finding on Digital Rectal Examination (DRE)
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 |
|---|---|---|
| Testosterone Undeconate (Nebido, BAY86-5037)Testosterone undecanoate 1000 mg (4 ml) i.m. injection at baseline, at week 6, at week 18, at week 30 and at week 42, respectively | Drug | Arm 1 |
| PlaceboMatching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively | Drug | Arm 2 |
Primary outcome
Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks
Time frame: At baseline, at week 54
8 secondary outcomes
Isometric maximum strength
Time frame: At baseline, at week 54
Grip strength
Time frame: At baseline, at week 54
Chair raising test
Time frame: At baseline, at week 54
Arm curl test
Time frame: At baseline, at week 54
Bicycle stress test with spirometry
Time frame: At baseline, at week 54
SF-36 Questionnaire
Time frame: At baseline, at week 54
AMS-Questionnaire
Time frame: At baseline, at week 54
FINGER Questionnaire
Time frame: At baseline, at week 54
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Click here and search for information of Bayer products for EuropeLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone Undeconate (Nebido, BAY86-5037) in people with Hypogonadism, run by Bayer at 1 site in Germany.
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 11 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: stopped early, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 stopped early. Results are not available in the source record.
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?
Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks (time frame: At baseline, at 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 5 Nov 2014.