UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endometriosis Promotion Project
Title of the study (Brief title)	Endometriosis Promotion Project
Region	Japan Asia(except Japan)

Condition
Condition	endometriosis
Classification by specialty	Obsterics 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Khaleque Khan
Organization	Kyoto Prefectural University of Medicine
Division name	Obstetrics and Gynecology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5560
Email	nemokhan@koto.kpu-m.ac.jp

Public contact
Name of contact person	Khaleque Khan
Organization	Kyoto Prefectural University of Medicine
Division name	Obstetrics and Gynecology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5560
Homepage URL
Email	nemokhan@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026057