UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028102 |
|---|---|
| Receipt number | 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 15:12:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hoda@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032169
