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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033962
Receipt No. 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

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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
Email 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
Email mukai@endmet.med.osaka-u.ac.jp

Sponsor
Institute Department of Metabolic Medicine. Osaka University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034910

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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