UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003501 |
|---|---|
| Receipt number | R000004245 |
| Scientific Title | The effect of testosterone replacement on metabolism and QOL of the male patients with secondary hypogonadism |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2010/04/17 12:10:41 |
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Basic information
Public title
The effect of testosterone replacement on metabolism and QOL of the male patients with secondary hypogonadism
Acronym
The effect of testosterone replacement on metabolism and QOL of the male patients with secondary hypogonadism
Scientific Title
The effect of testosterone replacement on metabolism and QOL of the male patients with secondary hypogonadism
Scientific Title:Acronym
The effect of testosterone replacement on metabolism and QOL of the male patients with secondary hypogonadism
Region
| Japan |
Condition
Condition
secondary hypogonadism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We resarch the effect of testosterone replacement on metabolism and QOL of the patients with secondary hypogonadism. And we compare the effect between testosterone enanthate i.m. and testosterone ointment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL,insulin resistance, dyslipidemia, body wieght,west circumference,visceral fat,marker of oxidative stress and arteriosclerosis
Key secondary outcomes
side effect, bone metabolism, other pituitary hormones, basal metabolism
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
testosterone ointment
Interventions/Control_2
testosterone enanthate
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
The patients with low serum testosterone with low or relative low serum gonadotrophins
Key exclusion criteria
The patients with sever chronic heart failure, sever chronic renal failure, sever hepatic dysfunction or history of prostate cancer. And the patients with high serum PSA above 4ng/dl
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kitamura Tetsuhiro |
Organization
Osaka University Graduate school of Medicine
Division name
Department of Endocrinology
Zip code
Address
2-2 Yamadaoka, Suitashi, Osaka 565-0871, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate school of Medicine
Division name
Department of Endocrinology
Zip code
Address
TEL
Homepage URL
tkitamura@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Endocrinology, Osaka University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 17 | Day |
Last modified on
| 2010 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004245
