Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000363482
Ethics application status
Not yet submitted
Date submitted
4/07/2007
Date registered
9/07/2007
Date last updated
9/07/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
The Role of Androgens in Angiogenesis and Endothelial Progenitor Cell Mobilisation
Scientific title
The Effect of Androgen Therapy on Endothelial Progenitor Cell Mobilisation and Function in Healthy Men
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular effects of testosterone therapy in healthy men, specifically mobilisation and function of endothelial progenitor cells. 1941 0
Condition category
Condition code
Cardiovascular 2038 2038 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Testosterone Undecanoate (1000mg) one intramuscular injection on randomisation and one injection at 6 weeks only.

The participants will return for follow-up assessment at week 12 (1 month post final injection) and at week 16.
Intervention code [1] 1874 0
Treatment: Drugs
Comparator / control treatment
Control: Intramuscular injection of normal saline (4mL - equal to the volume of IM testosterone) at randomisation and at 6 weeks only.
The participants will return for follow-up assessment at week 12 (1 month post final injection) and at week 16.
Control group
Placebo

Outcomes
Primary outcome [1] 2863 0
Endothelial progenitor cell number in peripheral blood as quantitated by flow cytometric analysis for CD34+/KDR+ and CD34+/CD133+ cells, respectively.
Timepoint [1] 2863 0
At 1 week, 6 weeks and 12 weeks.
Secondary outcome [1] 4826 0
Endothelial progenitor cell (EPC) function as assessed by standardised in vitro assays of EPC proliferation, migration and angiogenesis.
Timepoint [1] 4826 0
At 1 week, 6 weeks and 12 weeks.

Eligibility
Key inclusion criteria
Two age-stratified groups of healthy, ambulatory men, comprising: 1) twenty men = 35 years of age and; 2) twenty men = 60 years of age will be asked to participate in this study.
Minimum age
35 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men will be excluded from the study if they have diseases of the prostate requiring medical or surgical treatment or have chronic medical diseases or medications likely to interfere with safe participation in androgen therapy.Specific exclusion criteria:Patients will be excluded from the study if any of the following criteria is fulfilled:a) Prostate disease still requiring further medical or surgical treatment. Men with an isolated elevation of PSA or with a history of prostatectomy for benign prostatic hyperplasia may be entered with the agreement of their own or the study urologist. If any doubt, volunteer may only enter study after urological review.b) Currently significant, inadequately controlled chronic medical diseases likely to interfere with safe participation. This includes severe chronic renal & liver disease; unstable chronic pulmonary or cardiovascular disease (including within 6 months of myocardial infarction); uncontrolled or severe hypertension, hyperlipidemia, obstructive sleep apnoea or polycythemia; or cancer with poor prognosis. c) Medical conditions which interfere with evaluation of main study end-points. This includes neuromuscular or skeletal diseases which interfere with reliable mobility or dynamometry testing. Patients with type I diabetes mellitus may be included but will not undergo insulin clamp testing. d) Medications interfering with evaluation of study end-points or changes in dosage during the study. e) Disallowed drugs include, androgens or other sex steroids, anti-androgens, cimetidine, spironolactone, GnRH analogs.f) Allowed medication include fixed doses throughout the study period of bisphosphonates, calcitriol, vitamins, statins, antihypertensives, glucocorticoids, benzodiazepines, over-the-counter & non-prescription medications, herbal medications, aspirin, paracetamol, non-steroidal anti-inflammatory drugs, opiates, anticoagulants.g) History of drug or alcohol abuse or psychological disorders requiring regular psychotrophic medication (other than benzodiazepines).h) Any other condition likely in the judgement of the investigator that makes the patient unable to complete, or unsuitable or unsafe for, the study.i) Any medical condition which in the judgement of the Investigator and sponsor may interfere with the absorption, distribution, metabolism or excretion of the drug. j) Refusal or inability to comply with the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation. Stratified allocation dependent on age.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The following people will be blinded in this study: the people receiving the treatment/s (subjects), the people administering the treatment/s (therapist or clinician), the people assessing the outcomes (assessor) and the people analysing the results/data (data analyst).
Phase
Phase 1
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2179 0
Government body
Name [1] 2179 0
National Health and Medical Research Council (NHMRC)
Country [1] 2179 0
Australia
Primary sponsor type
Individual
Name
Dr. Martin Ng, Royal Prince Alfred Hospital.
Address
Country
Australia
Secondary sponsor category [1] 1967 0
None
Name [1] 1967 0
None
Address [1] 1967 0
Country [1] 1967 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3976 0
Royal Prince Alfred Hospital
Ethics committee address [1] 3976 0
Ethics committee country [1] 3976 0
Australia
Date submitted for ethics approval [1] 3976 0
Approval date [1] 3976 0
Ethics approval number [1] 3976 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27688 0
Address 27688 0
Country 27688 0
Phone 27688 0
Fax 27688 0
Email 27688 0
Contact person for public queries
Name 11063 0
Dr. Martin Ng
Address 11063 0
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 11063 0
Australia
Phone 11063 0
+61 2 95156111
Fax 11063 0
+61 2 95506262
Email 11063 0
[email protected]
Contact person for scientific queries
Name 1991 0
Dr. Martin Ng
Address 1991 0
Department of Cardiology
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 1991 0
Australia
Phone 1991 0
+61 2 95156111
Fax 1991 0
+61 2 95506262
Email 1991 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.