Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000993695
Ethics application status
Approved
Date submitted
8/09/2014
Date registered
15/09/2014
Date last updated
15/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysis of the profile of males with hypogonadism in the regional setting of North Queensland.
Scientific title
Retrospective analysis of the profile of males with hypogonadism in a regional hospital of North Queensland,
Australia over the past 10 years
Secondary ID [1] 285302 0
nil
Universal Trial Number (UTN)
U1111-1161-4621
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypogonadism 292984 0
Condition category
Condition code
Metabolic and Endocrine 293275 293275 0 0
Other metabolic disorders
Public Health 293319 293319 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We are doing a retrospective chart study on the profile of males who have developed hypogonadism within Mackay Base Hospital over the last 10 years. We will be looking at the patient's demographic profile, previous medical conditions/surgeries/medication, the symptoms that led them to the diagnosis (fatigue, headache, loss of libido, infertility, low mood), previous examination findings (weight/BMI, neurological finidngs, blood sugar, testicular examination) any investigation results (biochemical or radiological and risk factors for developing the disease (alcohol, radiation, drug-usage, smoking history). All information will be gathered from charts (with previous history of hypogonadism) within Mackay Base Hospital , and relevent information will be transferred to the database collection tool. No patient contact is involved. (passed through ethics and public health act).
Intervention code [1] 290211 0
Not applicable
Comparator / control treatment
Nil treatment provided as it is a chart study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293114 0
A validated data collection tool is being used collect data and analyse the profile of males with hypogonadism. This data collecting tool has been approved by Townsville Human Research Ethics committee and Public Health Act. This data collection tool was made by our own research group. Things that we are looking for whilst analysing data from patient charts include; patient demographics, symptoms that led to the diagnosis, previous medical and surgical history, examination findings, investigation findings (biochemical- serum testosterone, lipids, blood sugars, prolactin, thyroid hormone, and radiological- ct/mri head, ultrasound of testes), and exposure risk factors.
Timepoint [1] 293114 0
We have been granted approval by Townsville Human Research Ethics committee and Public Health Act/Mackay Base Hospital to have access to all patients who have developed hypogonadism within the last 10 years. Thus outcomes for each patient are assessed when they contracted the disease. Usually there a few cases annually. This information will be collected retrospectively from charts.
Secondary outcome [1] 310386 0
To look at the complications developed by patients who have suffered from hypogonadism. These include metabolic syndrome, diabetes, hyperlipidemia, depression.
Timepoint [1] 310386 0
It depends on when the patient suffered the complication (usually after diagnosis). This data will be collected from patient charts.

Eligibility
Key inclusion criteria
all patients aged over 18 years with biochemical hypogonadism within Mackay Base Hospital in the period of June 2004-June 2014
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under the age of 18, severe chronic renal failure, or liver cirrhosis.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
As it is a retrospective chart study study, we only needed the patients who have been diagnosed with hypogonadism. We will be using simple demographical statistics (via MICROSOFT EXCEL) with the aid of graphs, and tables to help evaluate and present our statistics

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/09/2014
Actual
Date of last participant enrolment
Anticipated
31/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2968 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 8679 0
4740 - Mackay West

Funding & Sponsors
Funding source category [1] 289922 0
Hospital
Name [1] 289922 0
Mackay Base Hospital in-kind costs
Country [1] 289922 0
Australia
Primary sponsor type
Individual
Name
Apoorva Saboo
Address
Apoorva Saboo
James Cook University
PO BOX 6314
Mackay Mail Centre
QLD 4741
Country
Australia
Secondary sponsor category [1] 288612 0
Individual
Name [1] 288612 0
Pirathaban Sivabalan
Address [1] 288612 0
2 Griffin Street, Mackay, QLD, 4740
James Cook University
Country [1] 288612 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The rationale of this project is to study hypogonadism in the background of regional north Queensland. In the setting of a small population with a relatively variable socioeconomic status attributed to the mining and farming industry, it is interesting to evaluate the different causes of hypogonadism ranging from pathological causes to lifestyle choices with respect to exogenous steroid intake and a widespread use of complementary and alternative medicines. This study will also be stratifying how the level of testosterone may provide an insight to the primary general practitioner as to the possible causes of hypogonadism and if there is any correlation between the two parameters. Furthermore, a study on males with hypogonadism in regional Australia has not been previously undertaken.

With the knowledge that a low serum testosterone is known to provide various clinical complications such as increased microvascular disease, hyperlipidaemia, osteopenia, fatigue, weakness and psychological distress from impaired libido it is important to conquer these patients early and attempt to find any underlying cause behind these patients’ hypogonadism.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51294 0
Miss Apoorva Saboo
Address 51294 0
Apoorva Saboo James Cook University PO BOX 6314 Mackay Mail Centre QLD 4741
Country 51294 0
Australia
Phone 51294 0
61451045880
Fax 51294 0
Email 51294 0
apoorva.saboo@my.jcu.edu.au
Contact person for public queries
Name 51295 0
Mr Pirathaban Sivabalan
Address 51295 0
2 Griffin Street, Mackay, QLD, 4740 (James Cook University- Medical Student)
Country 51295 0
Australia
Phone 51295 0
61432472026
Fax 51295 0
Email 51295 0
pirathaban.sivabalan@my.jcu.edu.au
Contact person for scientific queries
Name 51296 0
Mr Pirathaban Sivabalan
Address 51296 0
2 Griffin Street, Mackay, QLD, 4740 (James Cook University-Medical Student)
Country 51296 0
Australia
Phone 51296 0
61432472026
Fax 51296 0
Email 51296 0
pirathaban.sivabalan@my.jcu.edu.au

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.