<!-- Alternate content for non-supporting browsers --> <h2>upgrade</h2> <h3>your browser</h3>
Home
Login
Contact us
Feedback
Register Trial
Trial Search
Latest News
FAQ
About Us
Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
001478
ACTR Number:
ACTRN12606000315516
Trial Status:
Registered
Date Submitted:
20/07/2006
Date Registered:
21/07/2006
Page 1
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
Update:
Reason:
ANZCTR registration 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
Update:
Reason:
Secondary ID:
UTN:
Update:
Reason:
Trial acronym:
TU/TU study
Update:
Page 2
Health condition(s) or problem(s) studied:
Male hypogonadism
Condition category:
Condition code:
Metabolic and Endocrine
Other metabolic and endocrine disorders
Page 3
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
Update:
Reason:
Intervention code:
Treatment: drugs
Comparator / control treatment:
No comparator.
Update:
Reason:
Control group:
Active
Update:
Reason:
Page 4
Primary outcome:
Individual and disease specific quality of life variables (reproductive hormones, subjective symptoms of androgen deficiency).
Timepoint:
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:
Androgen sensitive clinical measures (body composition, muscle strength, hemoglobin, sexual activity).
Timepoint:
These will be measured at baseline, + 12 weeks and at + 30 weeks for the TU arm and approximately 20 weeks for the TI arm.
Page 5
Key inclusion criteria:
Established androgen deficiency requiring testosterone replacement therapy. Otherwise medically stable. Able to understand and comply with the study design.
Update:
Reason:
Minimum Age:
18
Years
Update:
Reason:
Maximum Age:
No limit
Update:
Reason:
Gender:
Males
Update:
Reason:
Healthy volunteers?
No
Update:
Reason:
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.
Update:
Reason:
Page 6
Study type:
Interventional
Update:
Reason:
Purpose of the study:
Treatment
Update:
Allocation to intervention:
Randomised controlled trial
Update:
Reason:
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
double envelopes created by someone not directly involved in recruitment
Update:
Reason:
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
random number generator on computer
Update:
Reason:
Masking / blinding:
Open (masking not used)
Update:
Reason:
Update:
Reason:
Assignment:
Crossover
Update:
Reason:
Other design features (specify):
Update:
Reason:
Type of endpoint(s):
Safety/efficacy
Update:
Reason:
Update:
Reason:
Update:
Reason:
Update:
Reason:
Update:
Reason:
Page 7
Phase
Phase 4
Update:
Reason:
Anticipated or actual date of first participant enrolement:
17/07/2006
Update:
Reason:
Target sample size:
40
Update:
Reason:
Recruitment status:
Open to recruitment
Update:
Reason:
Page 8
Funding source:
Commercial sector/Industry
Name:
Schering Pty Ltd
Address:
Country:
Primary sponsor:
Commercial sector/Industry
Update:
Reason:
Name:
Schering Pty Ltd
Update:
Reason:
Address:
Update:
Reason:
Country:
Australia
Update:
Reason:
Secondary sponsor:
None
Name:
nil
Address:
Country:
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name:
Concord Repatriation General Hospital Human Research Ethics committee
Address:
Department of Clinical Andrology Building 22 CRGH Hospital Rd Concord 2139
Country:
Australia
Date of approval:
19/04/2006
HREC Number:
CH62/6/2006-016
Countries of recruitment:
Australia
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.
Update:
Reason:
Trial website:
Update:
Presentations / publication list:
Update:
Page 10
Contact person for public queries
Name:
Prof D J Handelsman
Update:
Reason:
Address:
ANZAC Research Institute CRGH Hospital Rd Concord NSW
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
02 9767 7100
Update:
Reason:
Fax:
02 9767 7221
Update:
Reason:
Email:
djh@med.usyd.edu.au
Update:
Reason:
Contact person for scientific queries
Name:
Ass Prof Ann Conway
Update:
Reason:
Address:
Department of Clinical Andrology Building 22 CRGH Hospital Rd. Concord NSW 2139
Update:
Reason:
Country:
Australia
Update:
Reason:
Tel:
02 9767 7222
Update:
Reason:
Fax:
02 9767 7221
Update:
Reason:
Email:
sharynk@med.usyd.edu.au
Update:
Reason:
Contact person responsible for updating information
Name:
Update:
Reason:
Address:
Update:
Reason:
Country:
Update:
Reason:
Tel:
Update:
Reason:
Fax:
Update:
Reason:
Email:
Update:
Reason:
