UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059982 |
|---|---|
| Receipt number | R000068573 |
| Scientific Title | Validation of optimal hormone levels in transgender women |
| Date of disclosure of the study information | 2025/12/04 |
| Last modified on | 2025/12/04 20:01:18 |
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Basic information
Public title
Validation of optimal hormone levels in transgender women
Acronym
Validation of optimal hormone levels in transgender women
Scientific Title
Validation of optimal hormone levels in transgender women
Scientific Title:Acronym
Validation of optimal hormone levels in transgender women
Region
| Japan |
Condition
Condition
transgender women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate optimal testosterone and estradiol levels in transgender women
Basic objectives2
Others
Basic objectives -Others
To examine the correlation between testosterone and estradiol levels and quality of life
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between WHO-QOL assessment and hormone levels
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
Key inclusion criteria
Transgender women undergoing gender-affirming hormone therapy
Key exclusion criteria
Transgender women who undergo gender-affiming surgery
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Baba |
Organization
Sapporo Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
060-8543
Address
South 1 West 16, Chu-o-ku, Sapporo, Hokkaido
TEL
0116112111
tbaba@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Baba |
Organization
Sapporo Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
060-8543
Address
South 1 West 16, Chu-o-ku, Sapporo, Hokkaido
TEL
0116112111
Homepage URL
tbaba@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
South 1 West 16, Chu-o-ku, Sapporo, Hokkaido
Tel
0116112111
tbaba@sapmed.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
| 2025 | Year | 12 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2030 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Medical information and WHO-QOL questionnaire
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068573
