UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061580 |
|---|---|
| Receipt number | R000070451 |
| Scientific Title | A Qualitative Study of Information-Seeking and Decision-Making Regarding Gender-Affirming Hormone Therapy among Individuals with Gender Dysphoria or Gender Incongruence |
| Date of disclosure of the study information | 2026/07/15 |
| Last modified on | 2026/05/14 21:27:56 |
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Basic information
Public title
A Qualitative Study of Information-Seeking and Decision-Making Regarding Gender-Affirming Hormone Therapy among Individuals with Gender Dysphoria or Gender Incongruence
Acronym
INSIGHT Study
Scientific Title
A Qualitative Study of Information-Seeking and Decision-Making Regarding Gender-Affirming Hormone Therapy among Individuals with Gender Dysphoria or Gender Incongruence
Scientific Title:Acronym
INSIGHT Study
Region
| Japan |
Condition
Condition
Gender Incongruence
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify how individuals with gender dysphoria or gender incongruence who have considered or experienced hormone therapy seek and refer to information about hormone therapy, and how they position healthcare professionals, family, friends, and online information in their decision-making regarding the initiation, continuation, discontinuation, and revision of treatment methods. The results will serve as foundational data for considering how to support individuals in safely and confidently accessing information and making decisions in consultation with healthcare professionals.
Basic objectives2
Others
Basic objectives -Others
Qualitative study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative characteristics of information referencing and decision-making processes regarding hormone therapy.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who recognize themselves as having gender dysphoria, gender incongruence, or a related experience. Individuals who are considering, about to start, have started, are currently undergoing, have discontinued, or have previously undergone hormone therapy.
Key exclusion criteria
Individuals who, according to the principal investigator or co-investigator, would experience significant psychological distress as a result of participating in the study.
Individuals who are unable to participate in the study due to severe mental or physical symptoms.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuna |
| Middle name | |
| Last name | Matsuo |
Organization
Graduate school of Medicine, Nagoya University
Division name
Department of Urology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi Prefecture, Japan
TEL
+82-52-744-2985
matsuo.kazuna.i7@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuna |
| Middle name | |
| Last name | Matsuo |
Organization
Graduate school of Medicine, Nagoya University
Division name
Department of Urology
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture, Japan
TEL
+81-744-2985
Homepage URL
matsuo.kazuna.i7@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Urology, Graduate school of Medicine, Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital Institutional Review Board
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture, Japan
Tel
+81-52-744-2479
ethics@med.nagoya-u.ac.jp
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
| 2026 | Year | 07 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a qualitative research project targeting individuals undergoing hormone therapy due to gender dysphoria. Interviews will be conducted to examine the factors influencing decision-making regarding the initiation and modification of hormone therapy.
Management information
Registered date
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070451
