ANZCTR - Registration

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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

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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Male Hypogonadism

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Time profile of serum testosterone concentrations.

Timepoint [1]

12 weeks post each testosterone injection

Secondary outcome [1]

Time profile of serum DHT, estradiol, LH and FSH concentrations

Timepoint [1]

12 weeks post injection

Secondary outcome [2]

Patient preference will be measured by self administered Likert scale.

Timepoint [2]

At the completion of the study (24 weeks).

Secondary outcome [3]

Patient acceptability will be measured by self administered Likert scale.

Timepoint [3]

Immediately after both SC and IM injections and at the completion of the study (24 weeks).

Secondary outcome [4]

Patient pain will be measured by self administered Likert scale

Timepoint [4]

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

Sex

Males

Can healthy volunteers participate?

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

4/03/2013

Actual

12/02/2014

Date of last participant enrolment

Anticipated

28/12/2018

Actual

18/12/2017

Date of last data collection

Anticipated

Actual

12/06/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Concord Repatriation Hospital - Concord

Recruitment postcode(s) [1]

2139 - Concord Repatriation Hospital

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Concord Repatriation General Hospital

Address [1]

Concord Repatriation General Hospital
Hospital Rd, Concord, NSW, 2139

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney South West Area Health Service Human Research Ethics Committee( Concord Repatriation general Hospital Zone (EC00118)

Ethics committee address [1]

Concord Repatriation General Hospital, Hospital Road,Concord, NSW 2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/08/2012

Approval date [1]

16/10/2012

Ethics approval number [1]

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

Prof David Handelsman

Address

The Andrology Department Hospital Road Concord Repatriation General Hospital Concord, NSW, 2139

Country

Australia

Phone

612 97677222

Fax

612 97677221

djh@anzac.edu.au

Contact person for public queries

Name

Leo Turner

Address

The Andrology Department Hospital Road Concord Repatriation General Hospital Concord, NSW, 2139

Country

Australia

Phone

612 97677222

Fax

612 97677221

lturner@anzac.edu.au

Contact person for scientific queries

Name

David Handelsman

Address

The Andrology Department Hospital Road Concord Repatriation General Hospital Concord, NSW, 2139

Country

Australia

Phone

612 97677222

Fax

612 97677221

djh@anzac.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Pharmacokinetics and Acceptability of Subcutaneous Injection of Testosterone Undecanoate.	2019	https://dx.doi.org/10.1210/js.2019-00134

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically