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
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
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
Trial website
Trial related presentations / publications
Public notes

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
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
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.