HypogonadismPhase 4NCT00700024
Odense Androgen Study - The Effect of Testim and Training in Hypogonadal Men
A Phase 4 study testing Testim and Strength training in people with Hypogonadism and Metabolic Syndrome, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the effect of training and testim on Hypogonadism. Read more about this study
- Who is it for?
- Ages 65 to 78 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Metabolic Syndrome
- What is being tested?
- Testim and Strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2008to Feb 2010
- 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 65 to 78 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male 65-78
- Bioavailable testosterone < 7.3 nmol/L
- Waist > 94 cm
Who cannot join
- Haematocrit > 0.50
- Known c. prostate or PSA > 3 Myg/L
- Known malignant disease
- Alcohol or drug abuse
- BMI > 40 kg/m2
- Use of 5 alpha reductance inhibitors
- Plan to father children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men
The purpose of this study is to determine the effect of training and testim on Hypogonadism.
Read the detailed description
The effect of testim and training in hypogonadal men.
- Conditions
- Hypogonadism, Metabolic Syndrome
- Being tested
- Testim, Strength training, placebo
- Keywords
- Body composition, Physical activity, Metabolic syndrome
- Medical subject headings
- Hypogonadism, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestimDrug
Also called testosteron
50 mg/dose7day
Strength trainingBehavioural
Also called training
three times a week
placeboDrug
Also called gel
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | testim Receives: Drug: Testim |
| 2 | Experimental | placebo Receives: Drug: placebo |
| 3 | Experimental | training Receives: Behavioral: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass
Measured: january 2008-january 2010
Secondary outcomes (1)
Insulin sensitivity, Visceral fat/liver fat, Body fat, Waist, Physical conditions and physical strengths, Adiponectin, Lipid metabolism, Subjective sensation of energy, Urine cortisol, Sexual function, Serum testosterone
Measured: january 2008-january 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Marianne Andersen, Md, phd, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700024
- Sponsor's protocol ID
- 030
- Status last verified
- Sep 2009
- First submitted
- 16 Jun 2008
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kruse R, Petersson SJ, Christensen LL, Kristensen JM, Sabaratnam R, Ortenblad N, Andersen M, Hojlund K. Effect of long-term testosterone therapy on molecular regulators of skeletal muscle mass and fibre-type distribution in aging men with subnormal testosterone. Metabolism. 2020 Nov;112:154347. doi: 10.1016/j.metabol.2020.154347. Epub 2020 Aug 25.
PubMed 32853647Jensen RC, Christensen LL, Nielsen J, Schroder HD, Kvorning T, Gejl K, Hojlund K, Glintborg D, Andersen M. Mitochondria, glycogen, and lipid droplets in skeletal muscle during testosterone treatment and strength training: a randomized, double-blinded, placebo-controlled trial. Andrology. 2018 Jul;6(4):547-555. doi: 10.1111/andr.12492. Epub 2018 Apr 15.
PubMed 29656500Glintborg D, Christensen LL, Kvorning T, Larsen R, Brixen K, Hougaard DM, Richelsen B, Bruun JM, Andersen M. Strength training and testosterone treatment have opposing effects on migration inhibitor factor levels in ageing men. Mediators Inflamm. 2013;2013:539156. doi: 10.1155/2013/539156. Epub 2013 Sep 8.
PubMed 24089589Kvorning T, Christensen LL, Madsen K, Nielsen JL, Gejl KD, Brixen K, Andersen M. Mechanical muscle function and lean body mass during supervised strength training and testosterone therapy in aging men with low-normal testosterone levels. J Am Geriatr Soc. 2013 Jun;61(6):957-962. doi: 10.1111/jgs.12279. Epub 2013 Jun 3.
PubMed 23730808
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Testim and Training in a Population Based, Randomized, Placebo-controlled, Double-blinded Study of Hypogonadal Men
- ClinicalTrials.gov ID
- NCT00700024
- Acronym / sponsor ID
- 030
- Conditions
- Hypogonadism, Metabolic Syndrome
- Keywords
- Body composition, Physical activity, Metabolic syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 18 Jun 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.
The purpose of this study is to determine the effect of training and testim on Hypogonadism.
Detailed description
The effect of testim and training in hypogonadal men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Testimtestim |
| 2 | Experimental | Drug: placeboplacebo |
| 3 | Experimental | Behavioral: Strength trainingtraining |
Who may qualify
- Ages
- 65 to 78 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Male 65-78
- Bioavailable testosterone < 7.3 nmol/L
- Waist > 94 cm
Key exclusion criteria (7 listed)
- Haematocrit > 0.50
- Known c. prostate or PSA > 3 Myg/L
- Known malignant disease
- Alcohol or drug abuse
- BMI > 40 kg/m2
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 |
|---|---|---|
| TestimAlso: testosteron50 mg/dose7day | Drug | 1 |
| Strength trainingAlso: trainingthree times a week | Behavioural | 3 |
| placeboAlso: gelplacebo | Drug | 2 |
Primary outcome
Lean body mass
Time frame: january 2008-january 2010
1 secondary outcome
Insulin sensitivity, Visceral fat/liver fat, Body fat, Waist, Physical conditions and physical strengths, Adiponectin, Lipid metabolism, Subjective sensation of energy, Urine cortisol, Sexual function, Serum testosterone
Time frame: january 2008-january 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
- Derived from this study: PubMed 32853647Kruse R, Petersson SJ, Christensen LL, Kristensen JM, Sabaratnam R, Ortenblad N, Andersen M, Hojlund K. Effect of long-term testosterone therapy on molecular regulators of skeletal muscle mass and fibre-type distribution in aging men with subnormal testosterone. Metabolism. 2020 Nov;112:154347. doi: 10.1016/j.metabol.2020.154347. Epub 2020 Aug 25.
- Derived from this study: PubMed 29656500Jensen RC, Christensen LL, Nielsen J, Schroder HD, Kvorning T, Gejl K, Hojlund K, Glintborg D, Andersen M. Mitochondria, glycogen, and lipid droplets in skeletal muscle during testosterone treatment and strength training: a randomized, double-blinded, placebo-controlled trial. Andrology. 2018 Jul;6(4):547-555. doi: 10.1111/andr.12492. Epub 2018 Apr 15.
- Derived from this study: PubMed 24089589Glintborg D, Christensen LL, Kvorning T, Larsen R, Brixen K, Hougaard DM, Richelsen B, Bruun JM, Andersen M. Strength training and testosterone treatment have opposing effects on migration inhibitor factor levels in ageing men. Mediators Inflamm. 2013;2013:539156. doi: 10.1155/2013/539156. Epub 2013 Sep 8.
- Derived from this study: PubMed 23730808Kvorning T, Christensen LL, Madsen K, Nielsen JL, Gejl KD, Brixen K, Andersen M. Mechanical muscle function and lean body mass during supervised strength training and testosterone therapy in aging men with low-normal testosterone levels. J Am Geriatr Soc. 2013 Jun;61(6):957-962. doi: 10.1111/jgs.12279. Epub 2013 Jun 3.
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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.
Marianne Andersen, Md, phd principal investigator
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 Testim and Strength training in people with Hypogonadism and Metabolic Syndrome, run by Odense University Hospital at 1 site in Denmark.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Sep 2009. 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 Denmark. 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.
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?
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?
Lean body mass (time frame: january 2008-january 2010). 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 NCT00700024, which also lists 4 linked publications.
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 Sep 2009.