UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Investigation
Acronym
uterine myoma
Scientific Title
Investigation
Scientific Title:Acronym
uterine myoma
Region
| Japan |
Condition
Condition
uterine myoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Compare myoma volume using MRI
Key secondary outcomes
VAS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
To shoot the time of the same only MRI without cabergolin
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
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
Key exclusion criteria
(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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asuka Higuchi |
Organization
Shiga University of Medicine
Division name
Obstetrics and gynecology science
Zip code
Address
ootu city seta tukinowatyou
TEL
0775482267
hqgyne@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asuka higuchi |
Organization
Shiga University of Medicine
Division name
Obstetrics and gynecology science course
Zip code
Address
ootu city seta tukinowatyou
TEL
0775482267
Homepage URL
hqgyne@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medicine
Institute
Department
Personal name
Funding Source
Organization
self
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
| 2018 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2018 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036241
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
