UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033962 |
|---|---|
| Receipt number | R000034910 |
| Scientific Title | Clinical trial of testosterone replacement therapy for the male hypogonadotropic hypogonadism with pituitary or hypothalamic tumor. |
| Date of disclosure of the study information | 2018/08/30 |
| Last modified on | 2019/03/05 16:41:16 |
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Basic information
Public title
Clinical trial of testosterone replacement therapy for the male hypogonadotropic hypogonadism with pituitary or hypothalamic tumor.
Acronym
T trial
Scientific Title
Clinical trial of testosterone replacement therapy for the male hypogonadotropic hypogonadism with pituitary or hypothalamic tumor.
Scientific Title:Acronym
T trial
Region
| Japan |
Condition
Condition
the male hypogonadotropic hypogonadism with pituitary or hypothalamic tumor
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Invetigation for effects of testosterone replacement therapy on quality of life and metabolism in the male hypogonadotropic hypogonadism with pituitary or hypothalamic tumor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL(short form 36(SF-36), Agingmales' symptoms (AMS))
Key secondary outcomes
metabolic parameter, other hormones
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
teststeron replacement therapy (testosterone enanthate 250mg/4weeks, 48weeks)
Interventions/Control_2
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
| Not applicable |
Gender
Male
Key inclusion criteria
The patient who satisfies that total teststeron is low and LH is not high, and that other hormone is stable, and who don't receive testosterone or gonadotropin replacement therapy.
Key exclusion criteria
heart failure(NYHA >3degree), liver disease(AST >100IU/ml or ALT >100IU/ml), kidney disease(Cr >2.0mg/dl), prostatic cancer or PSA >4ng/dl, urinary symptom(IPSS >19points), high-risk for coronary disease (anamnesis of myocardial infarction, stroke, the past of unstable angina in recent three months), insufficient blood pressure control(sBP >160mmHg or dBP >100mmHg), polycytemia(Ht >50%), cognitive functional disorder, assignment hope. In addition, the patient who judged that the medical attendant is inappropriate is excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Otsuki Michio |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
Address
2-2, Yamadaoka, Suita-shi, Osaka
TEL
06-6879-3732
otsuki@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mukai Kosuke |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
Address
2-2, Yamadaoka, Suita-shi, Osaka
TEL
06-6879-3732
Homepage URL
mukai@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine. Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 08 | Month | 30 | 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
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034910
