Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000068763
Ethics application status
Approved
Date submitted
15/01/2013
Date registered
18/01/2013
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of Subcutaneous Injection (SC)
of Testosterone in an Oil Vehicle: Nandrolone (ND) in Healthy Volunteers
Scientific title
Pharmacokinetics of Subcutaneous Injection (SC)
of Testosterone in an Oil Vehicle: Nandrolone (ND) in Healthy Volunteers
Secondary ID [1] 281713 0
nil
Universal Trial Number (UTN)
u1111 1138 1713
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Male Hypogonadism 288025 0
Condition category
Condition code
Metabolic and Endocrine 288401 288401 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nandrolone Decanoate (ND) 100 mg in 2 mL oil vehicle administered as a single subcutaneous injection under the abdominal skin.
Intervention code [1] 286264 0
Treatment: Drugs
Comparator / control treatment
Intramuscular injections of Nandrolone Decanoate (ND) 100mgs in 1 mL vehicle, historical controls.
Historical controls are sourced from previous research.
Minto C, Howe C, Wishart S, Conway AJ, Handelsman DJ 1997 Pharmacokinetics and pharmacodynamics of nandrolone esters in oil vehicle: effects of ester, injection site and volume. J Pharmacol Exp Ther 281:93-102
Control group
Historical

Outcomes
Primary outcome [1] 288574 0
Primary:
Time profile of serum testosterone concentrations.
Timepoint [1] 288574 0
21 days for ND SC
Secondary outcome [1] 300488 0
Time profile of serum nandrolone ,
DHT, estradiol, LH and FSH concentrations
Timepoint [1] 300488 0
21 days

Eligibility
Key inclusion criteria
Inclusion:
* Healthy male volunteers
* Aged 18-55 yr
* Written, informed consent & willing to comply with study requirements
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Contraindication to nanadrolone
* Seeking fertility in the next year
* Involved in any professional or recreational activities requiring urine drug screening
* History of illicit drug abuse within last year
* 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
* Taking medications for antiplatelet or anticoagulant therapy


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)
Allocation is not consealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Plot the mean blood levels of nandrolone and testosterone and compare them with our historical data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2013
Actual
23/04/2013
Date of last participant enrolment
Anticipated
3/02/2014
Actual
16/08/2013
Date of last data collection
Anticipated
Actual
27/09/2013
Sample size
Target
12
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 377 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 6157 0
2139 - Concord Repatriation Hospital

Funding & Sponsors
Funding source category [1] 286524 0
Hospital
Name [1] 286524 0

Concord Repatriation General Hospital
Country [1] 286524 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] 285311 0
None
Name [1] 285311 0
Address [1] 285311 0
Country [1] 285311 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288597 0
Sydney South West Area Health Service Human Research Ethics Committee ( Concord Repatriation General Hospital Zone) (EC00118)
Ethics committee address [1] 288597 0
Concord Repatriation General Hospital
Hospital Road, Concord, NSW 2139
Ethics committee country [1] 288597 0
Australia
Date submitted for ethics approval [1] 288597 0
27/08/2012
Approval date [1] 288597 0
16/10/2012
Ethics approval number [1] 288597 0
HREC/12/CRGH/158

Summary
Brief summary
Although intramuscular 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 SC injection, if effective, may be used in these men.

Nandrolone decanoate (ND) Subcutaneous (SC) will be trialed in healthy volunteers,with a historical, intramuscular (IM) control data set.
This is the first stage of a 2 stage research study
Trial website
Trial related presentations / publications
Publication- J Clin Endocrinol Metab. 2014 Jul;99(7):2592-8. doi: 10.1210/jc.2014-1243. Epub 2014 Mar 31. Pharmacokinetic-pharmacodynamic study of subcutaneous injection of depot nandrolone decanoate using dried blood spots sampling coupled with ultrapressure liquid chromatography tandem mass spectrometry assays
Public notes
Nandrolone decanoate (ND) Subcutaneous (SC) will be trialed in healthy volunteers,with a historical, intramuscular (IM) control data set.
This is the first stage of a 2 stage research study

Contacts
Principal investigator
Name 36778 0
Prof David Handelsman
Address 36778 0
The Andrology Department
Hospital Road
Concord Repatriation General Hospital
Concord, NSW, 2139
Country 36778 0
Australia
Phone 36778 0
612 97677222
Fax 36778 0
612 97677221
Email 36778 0
[email protected]
Contact person for public queries
Name 36779 0
Mr Leo Turner
Address 36779 0
The Andrology Department
Hospital Road
Concord Repatriation General Hospital
Concord, NSW, 2139
Country 36779 0
Australia
Phone 36779 0
612 97677222
Fax 36779 0
612 97677221
Email 36779 0
[email protected]
Contact person for scientific queries
Name 36780 0
Prof David Handelsman
Address 36780 0
The Andrology Department
Hospital Road
Concord Repatriation General Hospital
Concord, NSW, 2139
Country 36780 0
Australia
Phone 36780 0
612 97677222
Fax 36780 0
612 97677221
Email 36780 0
[email protected]

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 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.