UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017627 |
|---|---|
| Receipt number | 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 08:52:40 |
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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
| Obstetrics 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
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
m-cihiro@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyusyu university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020332
