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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000017627
Receipt No. R000020332
Scientific Title Research on influence that dienogest and low dose estrogen progesterone gives protein S specific activity and the coagulation system
Date of disclosure of the study information 2015/05/20
Last modified on 2016/05/24

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Basic information
Public title Research on influence that dienogest and low dose estrogen progesterone gives protein S specific activity and the coagulation system
Acronym Effects of DNG and LEP gives to protein S specific activity
Scientific Title Research on influence that dienogest and low dose estrogen progesterone gives protein S specific activity and the coagulation system
Scientific Title:Acronym 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

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
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
1st name
Middle name
Last name KIYOKO KATO
Organization Kyusyu university hospital
Division name Obstetrics and gynecology
Zip code
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
1st name
Middle name
Last name chihiro minami
Organization Kyusyu university hospital
Division name Obstetrics and gynecology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2015 Year 03 Month 01 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020332

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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