Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
88 participants
INTERVENTIONAL
2009-01-31
2014-04-30
Brief Summary
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The investigators will recruit 140 ambulatory men with type 2 diabetes and a low serum testosterone level (\<10 nmol/L) from Austin Health Endocrine clinics, General Practise surgeries, and from the general public by direct consumer advertising via newspaper and other local media. Men will be randomised to either intramuscular testosterone undecanoate (Reandron 1000, Bayer Schering Pharma) or placebo. Men with contraindications to testosterone replacement or to intramuscular injections will be excluded from the study. All men will receive intramuscular testosterone or placebo injections at 0, 6, 18 and 30 weeks (a total of four injections).
All 140 study subjects will have a clinical and laboratory assessment at baseline, 18 weeks and at study end (40 weeks). All 140 subjects will also have imaging studies at baseline and at study end (40 weeks). The study protocol is outlined in more detail below:
Clinical and laboratory assessment (Baseline and repeated 18 weeks, 40 weeks) A full medical history and physical examination will be performed. Symptoms will be assessed by the following standardised questionnaires: 1) Androgen Deficiency in the Aging Male (ADAM); 2) Aging Male Symptom scale (AMS); 3) International Index of Erectile Dysfunction (IIED); 4) International Prostate Symptom Score (IPSS); 5) SF-36 (all five questionnaires are attached to Module 1).
Laboratory studies will consist of blood tests to measure total testosterone, fasting glucose, C-peptide, HBA1c and other routine parameters.
Imaging studies (Baseline and repeated at 40 weeks)
1. Body composition and bone mineral density by DEXA
2. Body composition by magnetic resonance imaging
3. Bony micro-architecture by high resolution quantitative computed tomography \[HR-pQCT\]),
4. Cardiac dimensions and function by transthoracic doppler echocardiography
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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1
Reandron 100 treatment
Reandron 1000
1000mg at 0,6,18,30 weeks
2
Placebo
placebo
placebo injection 0,6.18.30 weeks
Interventions
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Reandron 1000
1000mg at 0,6,18,30 weeks
placebo
placebo injection 0,6.18.30 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Testosterone less than 10 nmol/L
Exclusion Criteria
* Testosterone or
* IM injection
18 Years
65 Years
MALE
No
Sponsors
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Austin Health
OTHER_GOV
Responsible Party
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Mathis Grossmann
AProf
Principal Investigators
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Mathis Grossmann
Role: PRINCIPAL_INVESTIGATOR
Austin Health
Locations
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Austin Health
Melbourne, Victoria, Australia
Countries
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References
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Gianatti EJ, Dupuis P, Hoermann R, Zajac JD, Grossmann M. Effect of testosterone treatment on constitutional and sexual symptoms in men with type 2 diabetes in a randomized, placebo-controlled clinical trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3821-8. doi: 10.1210/jc.2014-1872. Epub 2014 Jun 30.
Other Identifiers
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Reandron 1000 (ZK 5488) 321399
Identifier Type: -
Identifier Source: org_study_id
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