UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006891 |
|---|---|
| Receipt number | R000007060 |
| Scientific Title | Randomized contorol trial to determine the Efficacy and Safety on suppression of recurrence after suegery with Dinagest or GnRH for endometriosis. |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2015/06/05 10:19:56 |
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Basic information
Public title
Randomized contorol trial to determine the Efficacy and Safety on suppression of recurrence after suegery with Dinagest or GnRH for endometriosis.
Acronym
Study of relapse control with genogest after opreration of endometriosis
Scientific Title
Randomized contorol trial to determine the Efficacy and Safety on suppression of recurrence after suegery with Dinagest or GnRH for endometriosis.
Scientific Title:Acronym
Study of relapse control with genogest after opreration of endometriosis
Region
| Japan |
Condition
Condition
endometriosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the pain relapse controlling effect and safety with two medicine, GnRH that has been used and oncoming generation drug genogest, used for the patient who will be done the conservation surgery of the endometriosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Pain relapse rate after the operation
Key secondary outcomes
Efficacy evaluation by objective opinion
Efficacy evaluation by change rate of VAS after the operation
Evaluation of QOL
Evaluation of safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment to the postsurgical patient with the endometriosis by genogest in the relapse prevention purpose
Interventions/Control_2
Treatment to the postsurgical patient with the endometriosis by GnRHa in the relapse prevention purpose
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
(a) Those who will do preserved operation for the endometriosis.
(b) Those who signed informed consent.
(c) Those who can do non-hormonal contraception for the examination period.
Key exclusion criteria
(a) Those who have an abnormal genital hemorrhage which is not diagnosed.
(b) The pregnant or lactational woman.
(c) Those who have had the side effect in the medicine made of GnRH or Genogest.
(d) Those who are judged improper by the researcher or the doctor.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Kudo |
Organization
Hiroshima University Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
Kasumi 1-2-3
TEL
082-257-5262
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maki Hyodo |
Organization
Hiroshima University Hospital
Division name
Obstetrics and Gynecology
Zip code
Address
Kasumi 1-2-3 Minami-ku Hiroshima
TEL
082-257-5262
Homepage URL
Sponsor or person
Institute
Hiroshima 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
広島大学病院、県立広島病院、安佐市民病院、尾道総合病院、呉医療センター、中国労災病院、中電病院、土谷総合病院、東広島医療センター、広島記念病院、広島総合病院、広島鉄道病院、三次中央病院（すべて広島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 15 | Day |
Last modified on
| 2015 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007060
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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