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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023447
Receipt No. R000026997
Scientific Title Psychophysiological study of Gender Identity Disorder
Date of disclosure of the study information 2016/09/01
Last modified on 2019/02/04

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Basic information
Public title Psychophysiological study of Gender Identity Disorder
Acronym Psychophysiological study of Gender Identity Disorder
Scientific Title Psychophysiological study of Gender Identity Disorder
Scientific Title:Acronym Psychophysiological study of Gender Identity Disorder
Region
Japan

Condition
Condition Gender Identity Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Through the Prepulse Inhibition test, we aim to reveal the pasthogenesis of Gender Identity Disorder
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The sensitivity and specificity of Prepulse Inhibition test for Gender Identity Disorder
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Prepulse Inhibition test, once
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria F64.0 of ICD-10
Key exclusion criteria F64.1, F64.2, F65.1 of ICD-10 and Disorders of sex development
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Yoneda
Organization Osaka Medical College
Division name Dept. of Neuropsychiatry
Zip code
Address 2-7 Daigakumachi Takatsuki-city Osaka
TEL 072-683-1221
Email psy002@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Koh
Organization Osaka Medical College
Division name Dept. of Neuropsychiatry
Zip code
Address 2-7 Daigakumachi Takatsuki-city Osaka
TEL 072-683-1221
Homepage URL
Email psy012@osaka-med.ac.jp

Sponsor
Institute Dept. of Neuropsychiatry, Osaka Medical College
Institute
Department

Funding Source
Organization Dept. of Neuropsychiatry, Osaka Medical College
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 大阪医科大学(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 09 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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
2018 Year 11 Month 30 Day
Date trial data considered complete
2018 Year 12 Month 30 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 02 Day
Last modified on
2019 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026997

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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