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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028102
Receipt No. R000032169
Scientific Title A comprehensive treatment for gender dysphoria.
Date of disclosure of the study information 2017/07/06
Last modified on 2017/07/06

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Basic information
Public title A comprehensive treatment for gender dysphoria.
Acronym A comprehensive treatment for gender dysphoria.
Scientific Title A comprehensive treatment for gender dysphoria.
Scientific Title:Acronym A comprehensive treatment for gender dysphoria.
Region
Japan

Condition
Condition gender dysphoria
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the efficacy of hormonal and mental treatments in FtM individuals
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Minnesota Multiphasic Personality Inventory(MMPI)
Key secondary outcomes hormone level

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Participants who had received cross-sex hormonal treatment
Interventions/Control_2 Participants who had not received cross-sex hormonal treatment
Interventions/Control_3 Participants who had received cross-sex hormonal treatment with psychotherapy
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
15 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Diagnosis of Gender Identity Disorder according to DSM-IV-TR criteria

Definitive diagnoses were made by two psychiatrists based on a consistency in the results of evaluation
Key exclusion criteria Participants who denied the essential gender identity or wished to undergo SRS due to mental disorder such as schizophrenia
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Oda
Organization Kansai Medical University
Division name Department of Neuropsychiatry
Zip code
Address 10-15 Fumizono-cho, Moriguchi City, Osaka 570-8506, Japan
TEL 06-6992-1001
Email hoda@takii.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Oda
Organization Kansai Medical University
Division name Department of Neuropsychiatry
Zip code
Address 10-15 Fumizono-cho, Moriguchi City, Osaka 570-8506, Japan
TEL 06-6992-1001
Homepage URL
Email hoda@takii.kmu.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Kansai Medical University
Institute
Department

Funding Source
Organization No funding sorce
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
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 関西医科大学総合医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 06 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 Completed
Date of protocol fixation
2003 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2004 Year 06 Month 24 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
2017 Year 07 Month 06 Day
Last modified on
2017 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032169

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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