Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000315516
Ethics application status
Approved
Date submitted
20/07/2006
Date registered
21/07/2006
Date last updated
21/07/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Quality of Life Outcomes and the Pharmacokinetic and Pharmacodynamic Sequelae of Testosterone Undecanoate Injections compared with Testosterone Implants for Androgen Replacement Therapy in men with Classical Male Hypogonadism
Scientific title
The Quality of Life Outcomes and the Pharmacokinetic and Pharmacodynamic Sequelae of Testosterone Undecanoate Injections compared with Testosterone Implants for Androgen Replacement Therapy in men with Classical Male Hypogonadism
Universal Trial Number (UTN)
Trial acronym
TU/TU study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Male hypogonadism 1286 0
Condition category
Condition code
Metabolic and Endocrine 1376 1376 0 0
Other metabolic and endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
40 men with classical androgen deficiency will trial both testosterone undecanoate 1000mg injections and 4 x 200mg Testosterone Implant pellets in a randomised sequence over a period of approximately one year
Intervention code [1] 1218 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 1877 0
Individual and disease specific quality of life variables (reproductive hormones, subjective symptoms of androgen deficiency).
Timepoint [1] 1877 0
These will be measured at baseline, +2weeks, +4 weeks, +6 weeks, +12 weeks, +18 weeks and +30 weeks for the TU arm of the study and baseline, +2 weeks, +4 weeks, +12 weeks and at approximately 20 weeks for the TI arm of the study.
Secondary outcome [1] 3320 0
Androgen sensitive clinical measures (body composition, muscle strength, hemoglobin, sexual activity).
Timepoint [1] 3320 0
These will be measured at baseline, + 12 weeks and at + 30 weeks for the TU arm and approximately 20 weeks for the TI arm.

Eligibility
Key inclusion criteria
Established androgen deficiency requiring testosterone replacement therapy. Otherwise medically stable. Able to understand and comply with the study design.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Known contraindications to androgen therapy (eg. prostate cancer). Known allergy to castor oil vehicle of injections. Known significant systemic or mental illness.

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)
double envelopes created by someone not directly involved in recruitment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator on computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1508 0
Commercial sector/Industry
Name [1] 1508 0
Schering Pty Ltd
Country [1] 1508 0
Primary sponsor type
Commercial sector/Industry
Name
Schering Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 1325 0
None
Name [1] 1325 0
nil
Address [1] 1325 0
Country [1] 1325 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2929 0
Concord Repatriation General Hospital Human Research Ethics committee
Ethics committee address [1] 2929 0
Department of Clinical Andrology Building 22 CRGH Hospital Rd Concord 2139
Ethics committee country [1] 2929 0
Australia
Date submitted for ethics approval [1] 2929 0
Approval date [1] 2929 0
19/04/2006
Ethics approval number [1] 2929 0
CH62/6/2006-016

Summary
Brief summary
This study is designed to determine whether men with androgen deficiency prefer a long acting injection that requires administration each three months or whether they prefer subcutaneously implanted testosterone pellets administered approximately each 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35614 0
Address 35614 0
Country 35614 0
Phone 35614 0
Fax 35614 0
Email 35614 0
Contact person for public queries
Name 10407 0
Prof D J Handelsman
Address 10407 0
ANZAC Research Institute
CRGH
Hospital Rd
Concord NSW
Country 10407 0
Australia
Phone 10407 0
02 9767 7100
Fax 10407 0
02 9767 7221
Email 10407 0
djh@med.usyd.edu.au
Contact person for scientific queries
Name 1335 0
Ass Prof Ann Conway
Address 1335 0
Department of Clinical Andrology
Building 22
CRGH
Hospital Rd.
Concord NSW 2139
Country 1335 0
Australia
Phone 1335 0
02 9767 7222
Fax 1335 0
02 9767 7221
Email 1335 0
sharynk@med.usyd.edu.au

No information has been provided regarding IPD availability


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.