Unique ID issued by UMIN | UMIN000031740 |
---|---|
Receipt number | R000036241 |
Scientific Title | Investigation |
Date of disclosure of the study information | 2018/05/01 |
Last modified on | 2018/09/09 17:30:22 |
Investigation
uterine myoma
Investigation
uterine myoma
Japan |
uterine myoma
Obstetrics and Gynecology |
Others
NO
Study the effect of reducing cabergoline reduction of uterine myoma on patients with uterine myoma with the effect of volume change by MRI as the main index
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Compare myoma volume using MRI
VAS
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
2
Treatment
Medicine |
MRI during the growth phase (7th day to 10th day of menstruation). Measure the size (volume) of uterine myoma. Oral administration of cabergolin for 16 weeks (Oral administration of cabergolin oral administration once a week, 0.25 mg per week( week for week 1 and week 2) 0.5 mg dose for week 3 to week 16 MRI again in the growth phase (7th day to 10th day of menstruation) at the 17th to 20th weeks after the start of therapy with no oral administration (non-oral administration group).
Also, size, symptoms, anemia, etc. of uterine myoma compared before and after treatment, or between groups.
To shoot the time of the same only MRI without cabergolin
20 | years-old | <= |
60 | years-old | > |
Female
1) Patients who are hospitalized or hospitalized at Obstetrics and Gynecology Department, Shiga Medical University Hospital during this research period
(2) Women admitting menstruation
(3) having uterine myoma
(4) There is hope for treatment
(5) With regard to participation in this research, those who obtained consent by signing the consent form by the principal
(1) A person with severe anemia (hemoglobin concentration is 8 g/dl or less)
(2) Those who have been confirmed from medical records or inquiries that allergies and severe side effects, which are thought to be attributable to research drugs, have developed (occurred) in the past
(3) Persons who are menopause at the beginning of registration
(4) Pregnant women and lactating women at the beginning of registration
(5) Other patients whose research responsibility / sharers judged inappropriate as subjects of this study
50
1st name | |
Middle name | |
Last name | Asuka Higuchi |
Shiga University of Medicine
Obstetrics and gynecology science
ootu city seta tukinowatyou
0775482267
hqgyne@belle.shiga-med.ac.jp
1st name | |
Middle name | |
Last name | Asuka higuchi |
Shiga University of Medicine
Obstetrics and gynecology science course
ootu city seta tukinowatyou
0775482267
hqgyne@belle.shiga-med.ac.jp
Shiga University of Medicine
self
Self funding
NO
2018 | Year | 05 | Month | 01 | Day |
Unpublished
Terminated
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 04 | Month | 01 | Day |
2018 | Year | 08 | Month | 31 | Day |
2018 | Year | 08 | Month | 31 | Day |
2018 | Year | 08 | Month | 31 | Day |
2018 | Year | 08 | Month | 31 | Day |
2018 | Year | 03 | Month | 15 | Day |
2018 | Year | 09 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036241