UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032406 |
|---|---|
| Receipt number | R000036643 |
| Scientific Title | The effect of hormone therapy on chronic inflammation of endometriosis |
| Date of disclosure of the study information | 2018/04/27 |
| Last modified on | 2021/05/02 21:59:15 |
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Basic information
Public title
The effect of hormone therapy on chronic inflammation of endometriosis
Acronym
The effect of Dienogest on chronic inflammation of endometriosis
Scientific Title
The effect of hormone therapy on chronic inflammation of endometriosis
Scientific Title:Acronym
The effect of Dienogest on chronic inflammation of endometriosis
Region
| Japan |
Condition
Condition
endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of Dienogest on inflammatory cytokine and immune cells in endometriosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the number of immune cells especially regulatory T cells
Key secondary outcomes
To assess the amount of inflammatory cytokines by ELISA or realtime PCR
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Inpatient for hysterectomy
can be informed consent
Key exclusion criteria
intaking hormone therapy except Dienogest
pregnancy women
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Taisuke |
| Middle name | |
| Last name | Mori |
Organization
Kyoto Prefectural University of Medicine
Division name
Obstetrics and Gynecology
Zip code
6028566
Address
465, Kajii-cho, Hirokoji, Kawaramachi-dori, Kyoto city, Kyoto, Japan
TEL
075-251-5560
moriman@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Sugahara |
Organization
Kyoto Prefectural University of Medicine
Division name
Obstetrics and Gynecology
Zip code
6028566
Address
465, Kajii-cho, Hirokoji, Kawaramachi-dori, Kyoto city, Kyoto, Japan
TEL
075-251-5560
Homepage URL
sghr-tky@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mochida pharmaceutical company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Hirokoji, Kawaramachi-dori, Kyoto city, Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2018 | Year | 04 | Month | 27 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 04 | Month | 27 | Day |
Last modified on
| 2021 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036643
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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