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Trial registered on ANZCTR


Registration number
ACTRN12606000404527
Ethics application status
Approved
Date submitted
13/09/2006
Date registered
14/09/2006
Date last updated
20/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised placebo-controlled trial of testosterone undecanoate in obese men as adjuvant therapy for a weight loss program
Scientific title
A randomised placebo-controlled trial of testosterone undecanoate in obese men as adjuvant therapy for a weight loss program
Secondary ID [1] 253398 0
.
Universal Trial Number (UTN)
Trial acronym
OSA-T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea (OSA) 1370 0
Condition category
Condition code
Respiratory 1464 1464 0 0
Sleep apnoea
Diet and Nutrition 1465 1465 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised placebo-controlled trial of testosterone undecanoate in obese men with obstructive slee apena (OSA) as adjunctive therapy for a weight loss programme.The study will be conducted on an ambulatory basis and involve OSA subjects who are about to commence a standard weight reduction program. Once deemed eligible for the study, at a Screening visit, patients will report to the laboratory every 6 weeks for 18 weeks. They will receive three injections of testosterone (3000mg in total) undecanoate at 0, 6 and 12 weeks. In addition, whilst reporting patients will undergo a variety of assessments including overnight polysomnographies at weeks 0, 6 and 18 weeks. Patient will then reassessed in recovery, at one year
Intervention code [1] 1358 0
Treatment: Drugs
Comparator / control treatment
Placebo oil
Control group
Placebo

Outcomes
Primary outcome [1] 2026 0
The primary outcome that will be measured is weight (kg) before and after treatment.
Timepoint [1] 2026 0
Weight will be measured at 0 and 18 weeks.
Secondary outcome [1] 3495 0
Body composition (bioimpedance, DEXA (bone densitometry), single-cut abdominal and thigh computed Tomography(CT)).
Timepoint [1] 3495 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [2] 3496 0
Anthropometry (waist, hip, thigh, arm, neck circumferences and skinfold thickness).
Timepoint [2] 3496 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [3] 3497 0
Basal metabolic rate
Timepoint [3] 3497 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [4] 3498 0
Food intake and exercise diary
Timepoint [4] 3498 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [5] 3499 0
Physical activity (Physical Activity Questionnaire, motion detection)
Timepoint [5] 3499 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [6] 3500 0
Muscle strength (Jamar handgrip dynamometry)
Timepoint [6] 3500 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [7] 3501 0
Insulin sensitivity (by Homeostasis Model Assessment, HOMA)
Timepoint [7] 3501 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [8] 3502 0
Blood hormone concentrations (total and free testosterone, estradiol, sex hormone binding globulin (SHBG)
Timepoint [8] 3502 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [9] 3503 0
Luteinising hormone (LH)
Timepoint [9] 3503 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [10] 3504 0
Follicle-stimulating hormone (FSH)
Timepoint [10] 3504 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [11] 3505 0
Quality of life /wellbeing (SF36, leading symptom scale)
Timepoint [11] 3505 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [12] 3506 0
Sexual function [International Index of Erectile Function (IIEF)
Timepoint [12] 3506 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [13] 3507 0
Brief Male Sexual Function Inventory (BMSFI)
Timepoint [13] 3507 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [14] 3508 0
Motivation (compliance, completion).
Timepoint [14] 3508 0
Outcome varibles will be measured whilst the subjects are reporting the laboratory.
Secondary outcome [15] 276093 0
Sleep and breathing (overnight in-laboratory polysomnography)
Timepoint [15] 276093 0
Sleep studies will be conducted at Baseline and then 7 weeks and 18 weeks after baseline.

Eligibility
Key inclusion criteria
No significant uncontrolled medical problems.
Minimum age
18 Years
Maximum age
Not stated
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Severe OSA ((minimum oxygen saturation < 65% or RDI > 80) requiring immediate treatment due to severity or increased associated risk (eg Transport worker), Use of drugs that alter androgen action, Contraindications to testosterone therapy, Desire for paternity within the next 12 months, Participation in sports that ban testosterone and require drug monitoring, Psychiatric disorders or drug abuse unless well controlled,Chronic medical conditions likely to interfere with or influence study treatment or safety unless well controlled.

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)
A researcher not directly involved in this study will be responsible for the randomisation of subjects and maintaining the blind until after the data analyses are complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation list will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A researcher not directly involved in this study will be responsible for the randomisation of subjects and maintaining the blind. Subjects, therapists and assessors will be blinded to which group the subjects are randomised to.
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)

Funding & Sponsors
Funding source category [1] 1601 0
Commercial sector/Industry
Name [1] 1601 0
Schering AG Australia Pty Ltd
Address [1] 1601 0
NA
Country [1] 1601 0
Australia
Primary sponsor type
Other
Name
The Woolcock Institute of Medical Research
Address
431 Glebe Point Rd, Glebe NSW 2037
Country
Australia
Secondary sponsor category [1] 1406 0
None
Name [1] 1406 0
Nil
Address [1] 1406 0
Country [1] 1406 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3049 0
Sydney South West Area Health Service- The Centre for Respiratory Failure and Sleep Disorders Royal Prince Alfred Hospital
Ethics committee address [1] 3049 0
Ethics committee country [1] 3049 0
Australia
Date submitted for ethics approval [1] 3049 0
Approval date [1] 3049 0
05/09/2006
Ethics approval number [1] 3049 0
X06-0133

Summary
Brief summary
This is a randomised placebo-controlled trial of testosterone undecanoate in obese men with obstructive slee apena as adjunctive therapy for a weight loss programme. The aim of the study is to evaluate the additional effect of testosterone replacement on weight loss and motivation in obese (BMI>30kg/m2) men with obstructive sleep apnea undergoing a weight reduction program. The primary endopint is weight loss after 4.5 months with other secondary endpoints including body composition, anthropometry, physical activity, metabolic markers (eg insulin sensitivity, basal metabolic rate) and blood hormone concentrations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27965 0
Address 27965 0
Country 27965 0
Phone 27965 0
Fax 27965 0
Email 27965 0
Contact person for public queries
Name 10547 0
Ms Sarah Newton-John
Address 10547 0
PO Box M77 Missenden Road
Camperdown NSW 2050
Country 10547 0
Australia
Phone 10547 0
+61 2 95156578
Fax 10547 0
+61 2 95505865
Email 10547 0
sarahnj@woolcock.org.au
Contact person for scientific queries
Name 1475 0
Ms Renee Crompton
Address 1475 0
Level 7 Page Chest Pavilion Building 14
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 1475 0
Australia
Phone 1475 0
+61 2 95157546
Fax 1475 0
+61 2 95575059
Email 1475 0
reneec@woolcock.org.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