UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comprehensive treatment for gender dysphoria.
Title of the study (Brief title)	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	Hiroyuki Oda
Organization	Kansai Medical University
Division name	Department of Neuropsychiatry
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	Hiroyuki Oda
Organization	Kansai Medical University
Division name	Department of Neuropsychiatry
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2003 Year 12 Month 10 Day
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

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Publication of results	Unpublished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