UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	sghr-tky@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036643