Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000358640
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
9/09/2005
Date last updated
9/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy And Safety Of Dihydrotestosterone (DHT) To Prevent Prostate Growth In Middle-Aged Men
Scientific title
Efficacy And Safety Of Dihydrotestosterone (DHT) To Prevent Prostate Growth In Middle-Aged Men
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nil 452 0
Generally healthy men 453 0
Condition category
Condition code
Other 529 529 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dihydrotestoerone for 2 years.
Intervention code [1] 356 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 609 0
Growth rate of total prostate volume measured by ultrasound across the whole study
Timepoint [1] 609 0
Measured across the study
Secondary outcome [1] 1273 0
Growth rate of central and peripheral prostate volumes measured by ultrasound.
Timepoint [1] 1273 0
Secondary outcome [2] 1274 0
Bone mineral density in total body, hip and spine as measured by DEXA across the whole study.
Timepoint [2] 1274 0

Eligibility
Key inclusion criteria
Generally healthy men over age 50 years of age without known prostate disease.
Minimum age
50 Years
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not known to investigators
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 588 0
Commercial sector/Industry
Name [1] 588 0
Ascend/Besin
Country [1] 588 0
Primary sponsor type
Commercial sector/Industry
Name
Ascend/Besin
Address
Country
Secondary sponsor category [1] 477 0
None
Name [1] 477 0
Nil
Address [1] 477 0
Country [1] 477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1643 0
SSWAHS
Ethics committee address [1] 1643 0
Ethics committee country [1] 1643 0
Australia
Date submitted for ethics approval [1] 1643 0
Approval date [1] 1643 0
Ethics approval number [1] 1643 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35908 0
Address 35908 0
Country 35908 0
Phone 35908 0
Fax 35908 0
Email 35908 0
Contact person for public queries
Name 9545 0
A Idan RN
Address 9545 0
Dihydrotestosteron (DHT) Study Co-ordinator
Department of Andrology
Concord Hospital
Concord NSW 2139
Country 9545 0
Australia
Phone 9545 0
+61 2 97677222
Fax 9545 0
Email 9545 0
turnev@email.cs.nsw.gov.au
Contact person for scientific queries
Name 473 0
Professor DJ Handelsman
Address 473 0
Department of Andrology
Concord Hospital
Concord NSW 2139
Country 473 0
Australia
Phone 473 0
+61 2 97677222
Fax 473 0
Email 473 0
djh@anzac.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.