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Trial registered on ANZCTR


Registration number
ACTRN12613000101785
Ethics application status
Approved
Date submitted
18/01/2013
Date registered
25/01/2013
Date last updated
26/11/2018
Date data sharing statement initially provided
26/11/2018
Date results information initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Research Study of Injections of Testosterone in an Oil Vehicle for men with Androgen Deficiency: Reandron (Testosterone Undecanoate) will be administered subcutaneously and intramuscularly.
Scientific title
Pharmacokinetics of Subcutaneous Injection of Testosterone in an Oil Vehicle: A Randomised crossover study of Reandron (Testosterone Undecanoate) given subcutaneously and intramuscularly in hypogonadal men.
Secondary ID [1] 281800 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Male Hypogonadism 288127 0
Condition category
Condition code
Metabolic and Endocrine 288506 288506 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Testosterone Undecanoate (TU) 1000mgs in 4 mL oil vehicle.
Arm 1,
Administered as a single subcutaneous (SC) injection under the abdominal skin.
Arm 2,
Administered as a single intramuscular (IM) injection into the buttock.
Participants will be randomised to one of the two arms. Then after 12 weeks will receive treatment in the second arm.
Intervention code [1] 286346 0
Treatment: Drugs
Comparator / control treatment
Testosterone Undecanoate (TU) 1000mgs in 4 mL oil vehicle administered as a single intramuscular (IM) injection into the buttock. (Standard treatment)
Control group
Active

Outcomes
Primary outcome [1] 288662 0
Time profile of serum testosterone concentrations.
Timepoint [1] 288662 0
12 weeks post each testosterone injection
Secondary outcome [1] 300723 0
Time profile of serum DHT, estradiol, LH and FSH concentrations
Timepoint [1] 300723 0
12 weeks post injection
Secondary outcome [2] 300725 0
Patient preference will be measured by self administered Likert scale.
Timepoint [2] 300725 0
At the completion of the study (24 weeks).
Secondary outcome [3] 300830 0
Patient acceptability will be measured by self administered Likert scale.
Timepoint [3] 300830 0
Immediately after both SC and IM injections and at the completion of the study (24 weeks).
Secondary outcome [4] 300831 0
Patient pain will be measured by self administered Likert scale
Timepoint [4] 300831 0
Immediately after the injections (SC and IM) and 24 hours post injections.

Eligibility
Key inclusion criteria
*Already receiving regular testosterone treatment.
*Written, informed consent & willing to comply with study requirements
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
*Contraindication to testosterone
*History of major psychiatric disease or psychological condition that may limit understanding and compliance with study requirements
*Regular medications that interfere with absorption, metabolism or action of testosterone which may require dosage change during the study
*Taking medications for antiplatelet or anticoagulant therapy

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 computer randomisation.
Then sealed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Nil
Phase
Phase 4
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis
Calculate non-compartmental PK parameters according to Gibaldi & Perrier. The primary descriptive and not comparative but will examine the data on a non-inferiority basis.

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] 436 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 6201 0
2139 - Concord Repatriation Hospital

Funding & Sponsors
Funding source category [1] 286586 0
Hospital
Name [1] 286586 0
Concord Repatriation General Hospital
Address [1] 286586 0
Concord Repatriation General Hospital
Hospital Rd, Concord, NSW, 2139
Country [1] 286586 0
Australia
Primary sponsor type
Hospital
Name
Sydney Local Health District
Address
Concord Repatriation General Hospital
Hospital Rd, Concord, NSW, 2139
Country
Australia
Secondary sponsor category [1] 285369 0
None
Name [1] 285369 0
Address [1] 285369 0
Country [1] 285369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288661 0
Sydney South West Area Health Service Human Research Ethics Committee( Concord Repatriation general Hospital Zone (EC00118)
Ethics committee address [1] 288661 0
Concord Repatriation General Hospital, Hospital Road,Concord, NSW 2139
Ethics committee country [1] 288661 0
Australia
Date submitted for ethics approval [1] 288661 0
13/08/2012
Approval date [1] 288661 0
16/10/2012
Ethics approval number [1] 288661 0
HREC/12/CRGH/158

Summary
Brief summary
Although intramuscular (IM) injections of androgen's are known to be effective, they result in varying degrees of pain at the injection site that may last for a day or two. These injections need to be given into a precise location of the buttocks and require staff with expert training.

Unlike many other injections these cannot be self-injected due to the difficulty of safely injecting into the buttocks. A SC injection, if effective, may be given by yourself in your own home, which would be more convenient to avoid extra medical visits as well as saving GP and hospital resources.

Many men who require androgen replacement therapy may have bleeding disorders or are on medications that may intentionally slow the ability of their blood to clot. These men have a theoretical risk of bleeding and a very large bruise deep in an important muscle may later become infected and cause significant disability. As a result men using these anti-clotting drugs are usually prescribed other forms of androgen replacement therapy that are not always optimal. A subcutaneous (SC) injection, if effective, may be used in these men.
This is a randomised crossover study of testosterone Undecanoate given subcutaneously and intramuscularly in patients receiving testosterone replacement therapy. Each participant will receive a single IM injection and a single (SC) injection of TU. An IM injection is standard of care and duration of action is approximately 12 weeks. It is expected a SC injection will have a duration of action of 12 weeks. Thus the study will take 24 weeks for each participant to complete both arms.

This is the second stage of a 2 stage research study. This is stage 2 of study ACTRN12613000068763
Trial website
Trial related presentations / publications
Public notes
This is a randomised crossover study of testosterone Undecanoate given subcutaneously and intramuscularly in patients receiving testosterone replacement therapy.
This is the second stage of a 2 stage research study. The study will take each participant 12 weeks to complete each arm of the study and thus 24 weeks to complete the entire study.
Stage 1 is registered. Trial ID is ACTRN12613000068763

Contacts
Principal investigator
Name 37162 0
Prof David Handelsman
Address 37162 0
The Andrology Department Hospital Road Concord Repatriation General Hospital Concord, NSW, 2139
Country 37162 0
Australia
Phone 37162 0
612 97677222
Fax 37162 0
612 97677221
Email 37162 0
djh@anzac.edu.au
Contact person for public queries
Name 37163 0
Mr Leo Turner
Address 37163 0
The Andrology Department Hospital Road Concord Repatriation General Hospital Concord, NSW, 2139
Country 37163 0
Australia
Phone 37163 0
612 97677222
Fax 37163 0
612 97677221
Email 37163 0
lturner@anzac.edu.au
Contact person for scientific queries
Name 37164 0
Prof David Handelsman
Address 37164 0
The Andrology Department Hospital Road Concord Repatriation General Hospital Concord, NSW, 2139
Country 37164 0
Australia
Phone 37164 0
612 97677222
Fax 37164 0
612 97677221
Email 37164 0
djh@anzac.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary