MaleIPASS NebidoNCT00410306
Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice
An observational study of Male and Hypogonadism, run by Bayer at 33 sites in 33 countries.
Trial summary
This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Male, Hypogonadism
- What is being tested?
- Testosterone Undecanoate (Nebido, BAY86-5037)
- How many people
- 1,493 participants
- Where
- 33 sitesin 33 countries
- Study dates
- Oct 2006to Jul 2010
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients from routine practice
Who may be able to join
- Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization
Who cannot join
- Patients presenting with contraindications as stated in the product information
Trial locations and contacts
33 sites in 33 countries.
33 sites in 33 countries
About this study
Official title: International, Multi-center Post Authorization Surveillance Study on the Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice (IPASS Nebido)
This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Male, Hypogonadism
- Being tested
- Testosterone Undecanoate (Nebido, BAY86-5037)
- Keywords
- Hypogonadism, Nebido, Testosterone, Observational Study
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Undecanoate (Nebido, BAY86-5037)Drug
Patients from routine practice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Testosterone Undecanoate (Nebido, BAY86-5037) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, adverse drug reactions, patient reported tolerability
Measured: during 4 injection intervals
Secondary outcomes (8)
Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation
Measured: after 4 injection intervals
Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation
Measured: after 4 injection intervals
Change in intensity of symptoms or disorders associated with low testosterone (hot flushes or excessive sweating, sleep disturbances, decreased physical strength and erectile dysfunction) from baseline to end of observation
Measured: after 4 injection intervals
Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable)
Measured: after 4 injection intervals
Treatment continuation rate
Measured: after 4 injection intervals
Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference)
Measured: during 4 injection intervals
Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides)
Measured: during 4 injection intervals
Digital rectal examination
Measured: during 4 injection intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startOct 2006
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,493 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
- NCT00410306
- Sponsor's protocol ID
- 14203
- Other IDs
- 2005/00888, MP-04199, NE0601, 39732, 2005
- Acronym
- IPASS Nebido
- Status last verified
- Sep 2010
- First submitted
- 11 Dec 2006
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multi-center Post Authorization Surveillance Study on the Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice (IPASS Nebido)
- ClinicalTrials.gov ID
- NCT00410306
- Acronym / sponsor ID
- IPASS Nebido / 14203
- Conditions
- Male, Hypogonadism
- Keywords
- Hypogonadism, Nebido, Testosterone, Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,493 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Dec 2006 (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.
This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Testosterone Undecanoate (Nebido, BAY86-5037) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from routine practice
Key inclusion criteria (1 listed)
- Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization
Key exclusion criteria (1 listed)
- Patients presenting with contraindications as stated in the product information
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 Undecanoate (Nebido, BAY86-5037)Patients from routine practice | Drug | Group 1 |
Primary outcome
Adverse events, adverse drug reactions, patient reported tolerability
Time frame: during 4 injection intervals
8 secondary outcomes
Change in laboratory values (total testosterone, estradiol, SHGB, FSH, LH) from baseline to end of observation
Time frame: after 4 injection intervals
Change in subjective assessment of the patient (overall sexual desire/libido, vigor/vitality, mood, ability to concentrate) from baseline to end of observation
Time frame: after 4 injection intervals
Change in intensity of symptoms or disorders associated with low testosterone (hot flushes or excessive sweating, sleep disturbances, decreased physical strength and erectile dysfunction) from baseline to end of observation
Time frame: after 4 injection intervals
Patient reported outcome at end of observation (satisfaction with current androgen therapy, comparison to previous androgen therapy, if applicable)
Time frame: after 4 injection intervals
Treatment continuation rate
Time frame: after 4 injection intervals
Vital signs and anthropometric measurements (Blood pressure, heart rate, weight and waist circumference)
Time frame: during 4 injection intervals
Laboratory values (PSA, hemoglobin, hematocrit, HbA1C, T-chol, HDL-chol, LDL-chol, triglycerides)
Time frame: during 4 injection intervals
Digital rectal examination
Time frame: during 4 injection intervals
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
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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
33 sites in 33 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male and Hypogonadism, run by Bayer at 33 sites in 33 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Australia, Austria, Bulgaria, Colombia, Czechia and 28 more countries. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events, adverse drug reactions, patient reported tolerability (time frame: during 4 injection intervals). 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 24 Sep 2010.