HypogonadismNCT00847314
Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients
An observational study of Hypogonadism, run by Bayer at 1 site in Germany.
Trial summary
With advancing age testosterone levels decline in men. Low testosterone levels plus certain symptoms are called "Late Onset Hypogonadism (LOH)". Adipose tissue may contribute to testosterone deficiency. Read more about this study
- Who is it for?
- Ages 35 to 64 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosterone Undeconate (Nebido-R, BAY86-5037)
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Oct 2008
- 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 35 to 64 years
- Men only
- No healthy volunteers
- Adult
Study population: Male patients in medical practices > 35yrs fulfilling all criteria for documentation.
Who may be able to join
- Male patients > 35yrs
- Waist Circumference > 102cm
- Clinically and biochemically confirmed hypogonadism (testosterone group)
- Willingness to attempt weight optimization
Who cannot join
- Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours
- hypersensitivity towards the active pharmaceutical ingredient or other ingredients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Testogel® / Nebido in Combination With a Standardised Exercise and Diet Programme in Hypogonadal Male Patients With Abdominal Obesity Compared With Exercise and Diet Programme
With advancing age testosterone levels decline in men. Low testosterone levels plus certain symptoms are called "Late Onset Hypogonadism (LOH)". Adipose tissue may contribute to testosterone deficiency. On the other hand testosterone deficiency again leads to a decrease in lean body mass and an increase in fat mass - one of the clinical signs / symptoms of LOH. Lifestyle changes (diet, exercise) alone or in combination with testosterone replacement (TRT), have an influence on the symptoms of LOH. The aim of this study is to assess the additional impact of TRT on Aging Male Symptom Score (AMS) and adiposity (waist circumference) in patients, who are on a diet and exercise program.
- Conditions
- Hypogonadism
- Being tested
- Testosterone Undeconate (Nebido-R, BAY86-5037)
- Keywords
- Hypogonadism, Abdominal obesity, Physical exercise, Testosterone
- Medical subject headings
- Hypogonadism, Obesity, Abdominal, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Undeconate (Nebido-R, BAY86-5037)Drug
Male patients > 35yrs in medical practices fulfilling all criteria for documentation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Testosterone Undeconate (Nebido-R, BAY86-5037) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist Circumference
Measured: At each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJun 2007
- Primary completionOct 2008
- Study completionOct 2008
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT00847314
- Sponsor's protocol ID
- 13899
- Other IDs
- NE0602
- Status last verified
- Jun 2013
- First submitted
- 17 Feb 2009
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Testogel® / Nebido in Combination With a Standardised Exercise and Diet Programme in Hypogonadal Male Patients With Abdominal Obesity Compared With Exercise and Diet Programme
- ClinicalTrials.gov ID
- NCT00847314
- Acronym / sponsor ID
- 13899
- Conditions
- Hypogonadism
- Keywords
- Hypogonadism, Abdominal obesity, Physical exercise, Testosterone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Feb 2009 (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.
With advancing age testosterone levels decline in men. Low testosterone levels plus certain symptoms are called "Late Onset Hypogonadism (LOH)". Adipose tissue may contribute to testosterone deficiency. On the other hand testosterone deficiency again leads to a decrease in lean body mass and an increase in fat mass - one of the clinical signs / symptoms of LOH. Lifestyle changes (diet, exercise) alone or in combination with testosterone replacement (TRT), have an influence on the symptoms of LOH. The aim of this study is to assess the additional impact of TRT on Aging Male Symptom Score (AMS) and adiposity (waist circumference) in patients, who are on a diet and exercise program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Testosterone Undeconate (Nebido-R, BAY86-5037) |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male patients in medical practices > 35yrs fulfilling all criteria for documentation.
Key inclusion criteria (4 listed)
- Male patients > 35yrs
- Waist Circumference > 102cm
- Clinically and biochemically confirmed hypogonadism (testosterone group)
- Willingness to attempt weight optimization
Key exclusion criteria (2 listed)
- Androgen dependent carcinoma of the prostate or male mammary gland, past or present history of liver tumours
- hypersensitivity towards the active pharmaceutical ingredient or other ingredients.
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-R, BAY86-5037)Male patients > 35yrs in medical practices fulfilling all criteria for documentation. | Drug | Group 1 |
Primary outcome
Waist Circumference
Time frame: At each visit
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 21 Jun 2013.
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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?
An observational study of 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 4 inclusion and 2 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 21 Jun 2013. 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. 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?
Waist Circumference (time frame: At each visit). 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 21 Jun 2013.