UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on influence that dienogest and low dose estrogen progesterone gives protein S specific activity and the coagulation system
Title of the study (Brief title)	Effects of DNG and LEP gives to protein S specific activity
Region	Japan

Condition
Condition	Endometriosis
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Dienogest and low dose estrogen progesteron is to reveal the influence of the protein S specific activity.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	protein S specific activity
Key secondary outcomes	coagulation system

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	20 years-old <=
Age-upper limit	45 years-old >
Gender	Female
Key inclusion criteria	Patient of the taking of dienogest or low dose estrogen progestin for endometriosis treatment .
Key exclusion criteria	Patient who cannot use dienogest and low dose estrogen progestin
Target sample size	50

Research contact person
Name of lead principal investigator	KIYOKO KATO
Organization	Kyusyu university hospital
Division name	Obstetrics and gynecology
Address	3-1-1 maidashi higasiku,fukuoka-city
TEL	092-642-5395
Email	m-cihiro@med.kyushu-u.ac.jp

Public contact
Name of contact person	chihiro minami
Organization	Kyusyu university hospital
Division name	Obstetrics and gynecology
Address	3-1-1 maidashi higasiku,fukuoka-city
TEL	092-642-5395
Homepage URL
Email	m-cihiro@med.kyushu-u.ac.jp

Sponsor
Institute	Kyusyu university hospital
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	Kyusyu university hospital
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	九州大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2016 Year 03 Month 30 Day
Date of closure to data entry	2016 Year 03 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective study

Management information
Registered date	2015 Year 05 Month 20 Day
Last modified on	2016 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020332