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Trial registered on ANZCTR


Registration number
ACTRN12616000577415
Ethics application status
Approved
Date submitted
28/04/2016
Date registered
4/05/2016
Date last updated
4/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of testosterone on urea metabolism in men with hypogonadism
Scientific title
Effects of testosterone on urea metabolism in men with hypogonadism
Secondary ID [1] 289093 0
None
Universal Trial Number (UTN)
NA
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypogonadism 298552 0
Condition category
Condition code
Metabolic and Endocrine 298635 298635 0 0
Other endocrine disorders
Metabolic and Endocrine 298673 298673 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are studied at baseline, and then after two weeks of transdermal testosterone (Testogel; Besins Healthcare Australia Pty Ltd, 10mg /g) administration on upper back/shoulders at a dose of 100 mg/day once daily in the morning. Adherence will be monitored by empty drug packet return.
Intervention code [1] 294600 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298130 0
Urea metabolism, assessed by plasma urea turnover studies using stable isotopes
Timepoint [1] 298130 0
At baseline and 2 weeks post commencement of testosterone treatment.
Secondary outcome [1] 323242 0
Protein metabolism by plasma leucine turnover studies using stable isotopes
Timepoint [1] 323242 0
At baseline and 2 weeks post commencement of testosterone treatment.

Eligibility
Key inclusion criteria
1. Diagnosed hypogonadism;
2. Adequate replacement of other hormones in case of hypopituitarism;
3. Able to comprehend the requirements and procedures for the study and to provide informed consent before entering the study


Minimum age
18 Years
Maximum age
75 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any acute condition or exacerbation of chronic conditions that in the investigators opinion would interfere with the trial visit schedule and procedures;
2. Cancer, diabetes mellitus, immunosuppressive steroid therapy and chronic renal or hepatic illnesses;
3. People in existing dependent or unequal relationships with any member of the research team;
4. People who may be involved in illegal activity;
5. People highly dependent on medical care;
6. Patients who had received an investigational new drug within the last 6 month;
7. Patients with a cognitive impairment, an intellectual disability or a mental condition which interfere with the patient's ability to understand the requirements of the study;
8. Inability to give written informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NA
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Standard descriptive and statistical modelling approaches will be employed to analyse the data. Specifically, the treatment effects will be analysed by paired t-tests. Regression analysis will be used to determine the correlations between urea production rates and other endpoint measures. Sample size was calculated from our previous published data on the effects of testosterone on protein metabolism using similar investigation methods and sample size of 8 was determined at 80% power at p< 0.05 significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5695 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 13181 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 293468 0
University
Name [1] 293468 0
Western Sydney University
Address [1] 293468 0
Locked Bag 1797
Penrith NSW 2751
Australia
Country [1] 293468 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Westmead Hospital, Institute Road, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 292291 0
None
Name [1] 292291 0
None
Address [1] 292291 0
NA
Country [1] 292291 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294910 0
WSLHD Human Research Ethics Committee
Ethics committee address [1] 294910 0
Westmead Hospital, Institute Rd, Westmead NSW 2145
Ethics committee country [1] 294910 0
Australia
Date submitted for ethics approval [1] 294910 0
04/06/2014
Approval date [1] 294910 0
04/12/2014
Ethics approval number [1] 294910 0
HREC/14/WMEAD/138 (3973)

Summary
Brief summary
Patients with diagnosed hypogonadism will be studied at baseline and then after 2 weeks of testosterone replacement initiation at usual therapeutic doses (10 g Testogel). The study will involve measurements of urea metabolism, and whole body protein breakdown and oxidation, and how much of the amino acids are being recycled for new protein synthesis.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 65438 0
Dr Vita Birzniece
Address 65438 0
Blacktown Clinical School, School of Medicine
Western Sydney University, Locked Bag 1797,
Penrith NSW 2751
Australia
Country 65438 0
Australia
Phone 65438 0
+61298516059
Fax 65438 0
+61298516050
Email 65438 0
v.birzniece@westernsydney.edu.au
Contact person for public queries
Name 65439 0
Dr Vita Birzniece
Address 65439 0
Blacktown Clinical School, School of Medicine
Western Sydney University, Locked Bag 1797,
Penrith NSW 2751
Australia
Country 65439 0
Australia
Phone 65439 0
+61298516059
Fax 65439 0
+61298516050
Email 65439 0
v.birzniece@westernsydney.edu.au
Contact person for scientific queries
Name 65440 0
Dr Vita Birzniece
Address 65440 0
Blacktown Clinical School, School of Medicine
Western Sydney University, Locked Bag 1797,
Penrith NSW 2751
Australia
Country 65440 0
Australia
Phone 65440 0
+61298516059
Fax 65440 0
+61298516050
Email 65440 0
v.birzniece@westernsydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary