UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation
Title of the study (Brief title)	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	Asuka Higuchi
Organization	Shiga University of Medicine
Division name	Obstetrics and gynecology science
Address	ootu city seta tukinowatyou
TEL	0775482267
Email	hqgyne@belle.shiga-med.ac.jp

Public contact
Name of contact person	Asuka higuchi
Organization	Shiga University of Medicine
Division name	Obstetrics and gynecology science course
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000036241