UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001946 |
|---|---|
| Receipt number | R000001370 |
| Scientific Title | Utility of the ART for the LOH syndrome |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2023/01/16 13:15:42 |
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Basic information
Public title
Utility of the ART for the LOH syndrome
Acronym
Clinical trial about the utility of the androgen replacement therapy (ART) in late-onset hypogonadism (LOH) syndrome
Scientific Title
Utility of the ART for the LOH syndrome
Scientific Title:Acronym
Clinical trial about the utility of the androgen replacement therapy (ART) in late-onset hypogonadism (LOH) syndrome
Region
| Japan |
Condition
Condition
late-onset hypogonadism syndrome
Classification by specialty
| Medicine in general | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish utility of the ART for the LOH syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement of the subjective symptoms using question paper
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
testosterone drug
Interventions/Control_2
no treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
PSA < 2.0 ng/ml, Free-T < 11.8 pg/ml
Key exclusion criteria
Prostate cancer
serious complications
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikio Namiki |
Organization
kanazawa university
Division name
department of urology
Zip code
Address
13-1 Takara-machi, kanazawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
kanazawa university
Division name
department of urology
Zip code
Address
TEL
076-265-2393
Homepage URL
Sponsor or person
Institute
kanazawa university
Institute
Department
Personal name
Funding Source
Organization
Scientific research funds subsidy
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2007 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 07 | Day |
Last modified on
| 2023 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001370
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
