Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000952044
Ethics application status
Approved
Date submitted
29/10/2010
Date registered
5/11/2010
Date last updated
5/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Role of male sex hormone in Angiogenesis and Endothelial Progenitor Cell Mobilisation
Scientific title
The Role of Androgens in Angiogenesis and Endothelial Progenitor Cell Mobilisation
Secondary ID [1] 252985 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
effect of androgen on formation of new blood vessels 258524 0
Condition category
Condition code
Cardiovascular 258680 258680 0 0
Normal development and function of the cardiovascular system
Metabolic and Endocrine 258689 258689 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primoteston (testosterone enanthate) 250mg intramuscular injection weekly for 6 weeks
Intervention code [1] 257505 0
Treatment: Drugs
Intervention code [2] 257514 0
Prevention
Comparator / control treatment
placebo is normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 259537 0
endothelial progenitor cell functions assessment after treatment using in vitro assay (Asahara stain, Boyden chamber, and tubulogenesis assay), and in vivo model (cells transplanted to mice)
Timepoint [1] 259537 0
6 weeks after randomization (on completion of treatment)
Secondary outcome [1] 266152 0
effect on flow-mediated dilatation (FMD) of brachial artery using ultrasound
Timepoint [1] 266152 0
6 weeks after randomization (on completion of treatment)

Eligibility
Key inclusion criteria
all males, except for those aged 35-55 years old, and 18 is the minimum age
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
diabetes, prostate problem, on statin treatment, significant medical illness

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257957 0
Government body
Name [1] 257957 0
National and Health Medical Research Council
Country [1] 257957 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Heart Research Institute
Address
7 Eliza St, Newtown, NSW, 2042
Country
Australia
Secondary sponsor category [1] 257157 0
Individual
Name [1] 257157 0
Martin Ng
Address [1] 257157 0
Cardiology Department, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW 2050
Country [1] 257157 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259968 0
Ethics Review Committee (RPAH Zone) of the Sydney South West Area Health Service
Ethics committee address [1] 259968 0
Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW 2050
Ethics committee country [1] 259968 0
Australia
Date submitted for ethics approval [1] 259968 0
01/06/2007
Approval date [1] 259968 0
30/08/2007
Ethics approval number [1] 259968 0
X07-0159

Summary
Brief summary
This study aims to assess the effects of testosterone on endothelial progenitor cells numbers and function in men. By understanding the effects of testosterone on endothelial progenitor cells, we may be able to better understand the potential role that male sex hormones may play in maintaining heart and blood vessel function in men. This research may ultimately lead to new treatments to help with heart and blood vessel repair.

To Public:
This study aims to assess the effect of male sex hormone on the male stem cells. By understanding the effect we may be able to use male sex hormone to maintain human heart and blood vessel function in men.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31848 0
Address 31848 0
Country 31848 0
Phone 31848 0
Fax 31848 0
Email 31848 0
Contact person for public queries
Name 15095 0
Chi-Jen Hsu
Address 15095 0
7 Eliza St, Newtown, NSW, 2042
Country 15095 0
Australia
Phone 15095 0
+61-2-82088900
Fax 15095 0
Email 15095 0
[email protected]
Contact person for scientific queries
Name 6023 0
Chi-Jen Hsu
Address 6023 0
7 Eliza St, Newtown, NSW, 2042
Country 6023 0
Australia
Phone 6023 0
+61-2-82088900
Fax 6023 0
Email 6023 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.