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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018733
Receipt No. 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

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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
Obsterics 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
Email 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
Email zemlyajp@yahoo.co.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021648

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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