UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022853 |
|---|---|
| Receipt number | R000026057 |
| Scientific Title | Endometriosis Promotion Project |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2016/06/23 12:48:03 |
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Basic information
Public title
Endometriosis Promotion Project
Acronym
Endometriosis Promotion Project
Scientific Title
Endometriosis Promotion Project
Scientific Title:Acronym
Endometriosis Promotion Project
Region
| Japan | Asia(except Japan) |
Condition
Condition
endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pattern of cyclic or acyclic pain manifestation and their personal/social impact among teenage girls in some defined population in Kyoto and Thailand under the close supervision and guidance of Kyoto Prefectural Medical University in Kyoto, Japan and Mahidol University in Bangkok, Thailand.
Basic objectives2
Others
Basic objectives -Others
To compare the difference of high risked patients with endometriosis between Japan and Thailand.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The end point of this epidemiological study is to early identify and manage teenage girls with adolescent endometriosis.
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
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy women
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Khaleque Khan |
Organization
Kyoto Prefectural University of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5560
nemokhan@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Khaleque Khan |
Organization
Kyoto Prefectural University of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5560
Homepage URL
nemokhan@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 01 | 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
| 2016 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
under consideration byIRB
Management information
Registered date
| 2016 | Year | 06 | Month | 23 | Day |
Last modified on
| 2016 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026057
