UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of testosterone replacement therapy for the male hypogonadotropic hypogonadism with pituitary or hypothalamic tumor.
Title of the study (Brief title)	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	Otsuki Michio
Organization	Osaka University Graduate School of Medicine
Division name	Department of Metabolic Medicine
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	Mukai Kosuke
Organization	Osaka University Graduate School of Medicine
Division name	Department of Metabolic Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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