Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000114448
Ethics application status
Approved
Date submitted
31/08/2015
Date registered
2/02/2016
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
a study for dosage of Andriol Testocaps in treatment of late-onset hypogonadism
Scientific title
differential dosage of Andriol Testocaps in treatment of Chinese patients with late-onset hypogonadism
Secondary ID [1] 287252 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
late-onset hypogonadism 295867 0
Condition category
Condition code
Reproductive Health and Childbirth 296115 296115 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 297014 297014 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
lower dosage of Testosterone Undecanoate Capsule (Andriol) as two groups (40mg and 80mg orally. daily) for 12 weeks and monitored by drug tablet return
Intervention code [1] 292546 0
Treatment: Drugs
Comparator / control treatment
routine dosage(80mg orally per 12 hours) for 12 weeks
Control group
Dose comparison

Outcomes
Primary outcome [1] 295982 0
change in testosterone level with serum assay
Timepoint [1] 295982 0
three months post randomisation
Secondary outcome [1] 317091 0
proportion of participants with an improvement of LOH syndrome by Androgen Deficiency in the Aging Male questionnaire (ADAM)
Timepoint [1] 317091 0
three months post randomisation

Eligibility
Key inclusion criteria
Inclusion criteria:
1. serum testerone level <350ng/dl
2.decreased sexual desire
3. erection dysfunctiond

participants with all the 3 criteria together should be eligible
Minimum age
30 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1.abnormal PSA or prostate cancer
2.hematocrit>45%

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



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
12/02/2016
Actual
Date of last participant enrolment
Anticipated
1/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 7128 0
China
State/province [1] 7128 0
shanghai

Funding & Sponsors
Funding source category [1] 291940 0
Self funded/Unfunded
Name [1] 291940 0
unfunded
Country [1] 291940 0
Primary sponsor type
Individual
Name
zhou tie
Address
shanghai changhai road 168#, shanghai changhai hospital., shanghai, China, 200433
Country
China
Secondary sponsor category [1] 290610 0
None
Name [1] 290610 0
Address [1] 290610 0
Country [1] 290610 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293860 0
changhai hospital ethics committee
Ethics committee address [1] 293860 0
shanghai changhai road 168#, shanghai changhai hospital., shanghai, China, 200433
Ethics committee country [1] 293860 0
China
Date submitted for ethics approval [1] 293860 0
02/09/2015
Approval date [1] 293860 0
12/10/2015
Ethics approval number [1] 293860 0

Summary
Brief summary
Overload dosage of Andriol Testocaps will not benefit the patients with LOH. In China, the patients with LOH were administrated with same dosage of Andriol Testocaps but lower BMI or weight compared with the westerns. Obviously, drug dosage heavily depends on the weight and BMI. Thus if Chinese patients are given similar dosage of Andriol Testocaps to the western patients, they may face the overdosage of Andriol Testocaps. In this study, we investigate the appropriate dosage of Andriol Testocaps for Chinese patients with LOH.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59426 0
Prof zhou tie
Address 59426 0
shanghai changhai road 168#, shanghai changhai hospital., shanghai, China, 200433
Country 59426 0
China
Phone 59426 0
+8613918360523
Fax 59426 0
Email 59426 0
wenzhoutie80@yahoo.com
Contact person for public queries
Name 59427 0
Dr zhou tie
Address 59427 0
shanghai changhai road 168#, shanghai changhai hospital., shanghai, China, 200433
Country 59427 0
China
Phone 59427 0
+8613918360523
Fax 59427 0
Email 59427 0
wenzhoutie80@yahoo.com
Contact person for scientific queries
Name 59428 0
Dr zhou tie
Address 59428 0
shanghai changhai road 168#, shanghai changhai hospital., shanghai, China, 200433
Country 59428 0
China
Phone 59428 0
+8613918360523
Fax 59428 0
Email 59428 0
wenzhoutie80@yahoo.com

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.