Unique ID issued by UMIN | UMIN000006891 |
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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 |
Randomized contorol trial to determine the Efficacy and Safety on suppression of recurrence after suegery with Dinagest or GnRH for endometriosis.
Study of relapse control with genogest after opreration of endometriosis
Randomized contorol trial to determine the Efficacy and Safety on suppression of recurrence after suegery with Dinagest or GnRH for endometriosis.
Study of relapse control with genogest after opreration of endometriosis
Japan |
endometriosis
Obstetrics and Gynecology |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
Pain relapse rate after the operation
Efficacy evaluation by objective opinion
Efficacy evaluation by change rate of VAS after the operation
Evaluation of QOL
Evaluation of safety
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Treatment to the postsurgical patient with the endometriosis by genogest in the relapse prevention purpose
Treatment to the postsurgical patient with the endometriosis by GnRHa in the relapse prevention purpose
20 | years-old | <= |
50 | years-old | > |
Female
(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.
(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.
160
1st name | |
Middle name | |
Last name | Yoshiki Kudo |
Hiroshima University Hospital
Obstetrics and Gynecology
Kasumi 1-2-3
082-257-5262
1st name | |
Middle name | |
Last name | Maki Hyodo |
Hiroshima University Hospital
Obstetrics and Gynecology
Kasumi 1-2-3 Minami-ku Hiroshima
082-257-5262
Hiroshima University Hospital
none
Self funding
NO
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)
2012 | Year | 01 | Month | 01 | Day |
Partially published
Completed
2011 | Year | 08 | Month | 10 | Day |
2011 | Year | 09 | Month | 01 | Day |
2015 | Year | 12 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2011 | Year | 12 | Month | 15 | Day |
2015 | Year | 06 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007060
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