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
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
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
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
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.