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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031740
Receipt No. R000036241
Scientific Title Investigation
Date of disclosure of the study information 2018/05/01
Last modified on 2018/09/09

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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
Obsterics 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
Email 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
Email hqgyne@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036241

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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