UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018733 |
|---|---|
| Receipt number | R000021648 |
| Scientific Title | optimal dose dicision of Dienogest by serum Estradiol level for endometriosis |
| Date of disclosure of the study information | 2016/11/22 |
| Last modified on | 2016/11/22 16:01:26 |
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Basic information
Public title
optimal dose dicision of Dienogest by serum Estradiol level for endometriosis
Acronym
optimal dose dicision of Dienogest by serum Estradiol level for endometriosis
Scientific Title
optimal dose dicision of Dienogest by serum Estradiol level for endometriosis
Scientific Title:Acronym
optimal dose dicision of Dienogest by serum Estradiol level for endometriosis
Region
| Japan |
Condition
Condition
Endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reduce the side effect of Dienogest, we confirm the efficacy and safety of management with reduced quantity of Dienogest, and study whether we can predict a personal optimum dose with a blood estradiol level.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The possibility of management for endometriosis with the optimal dose of Dienogest witch decided from serum estradiol level.
Key secondary outcomes
Comparison of the physical profile between the normal quantity optimum group and reduced quantity optimum group.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The therapeutic level of blood E2 is 30-50pg/mL. Three menthes after start of 2 mg/day Dienogest treatment, we measure the serum E2 level. If that is less than 30pg/mL, 1 mg/day Dienogest treatment will be started. If that is over than 30pg/mL, 2 mg/day Dienogest treatment will be continued. Women treated with 1 mg/day Dienogest, three menthes after start of 1 mg/day Dienogest treatment, we measure the serum E2 level again. If that is less than 50pg/mL, 2 mg/day Dienogest treatment will be restarted.
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
1)Women with Endometriosis.
2)Women without wish for pregnancy right now.
3)Women whose best therapy is drug treatment.
4)Women who are well imformed and consented to perticipate this study.
5)Outpatient.
Key exclusion criteria
1)Women who hope pregnancy right now.
2)whomen who suspected with mallignancy desease.
3)Women who are considerd inadequate to perticipate this study by investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kamada Yasuhiko |
Organization
Okayama University Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan 700-8558
TEL
086-235-7320
zemlyajp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Kamada |
Organization
Okayama University Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan 700-8558
TEL
086-235-7320
Homepage URL
https://www.okayama-u-obgyn.jp/torikumi/rinri_research.html
zemlyajp@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 20 | Day |
Last modified on
| 2016 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021648
