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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046174
Receipt No. R000052498
Scientific Title von Willebrand disease (VWD) screening in Japanese women visiting gynecologists to treat menorrhagia or dysmenorrhea without a definitive diagnosis of the underlying causative disease for abnormal bleeding
Date of disclosure of the study information 2021/11/26
Last modified on 2021/11/26

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Basic information
Public title von Willebrand disease (VWD) screening in Japanese women visiting gynecologists to treat menorrhagia or dysmenorrhea without a definitive diagnosis of the underlying causative disease for abnormal bleeding
Acronym VWD screening Study
Scientific Title von Willebrand disease (VWD) screening in Japanese women visiting gynecologists to treat menorrhagia or dysmenorrhea without a definitive diagnosis of the underlying causative disease for abnormal bleeding
Scientific Title:Acronym VWD screening Study
Region
Japan

Condition
Condition Menorrhagia or dysmenorrhea with abnormal bleeding
Classification by specialty
Hematology and clinical oncology Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate the proportion of Japanese women with undiagnosed von Willebrand disease (VWD) or other suspected coagulation abnormalities who have menorrhagia or dysmenorrhea with abnormal bleeding and are visiting a gynecologist.
Basic objectives2 Others
Basic objectives -Others Non-interventional, clinical study
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The proportion of patients with suspected VWD or other suspected coagulation abnormalities
Key secondary outcomes Blood test results, treatment status of menorrhagia or dysmenorrhea with abnormal bleeding, and distribution of bleeding tendency for all enrolled patients and for the VWD and non-VWD groups, respectively.
Stratified analysis by background factors and by subtype of VWD in the VWD group.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria 1.Patients who are judged by the investigator or the subinvestigator to understand the contents of this study and to be able to comply with them.
2.If the patient and the minor patient's legally acceptable representative are able to sign and date the consent and explanation documents before this study procedure is conducted.
3.Japanese women who visit the outpatient clinic of obstetrics and gynecology with the main complaint of menorrhagia or dysmenorrhea with abnormal bleeding.
4.Patients with the abnormal bleeding in the cervix or uterine cavity
5.Patients whose menstruction prior to the start of treatment meets one or more of the following criteria.
A)Bleeding volume of 140 mL or more per menstrual cycle.
B)Blood clots of 2.5 cm or more in diameter.
C)Menstrual periods of 8 days or more.
D)A requirement to change sanitary pads or tampons more often than hourly, or at risk of flooding not contained within a pad/tampon at night when wearing the night size, or a need for using the night size during the day.
E)Menstrual anemia (hemoglobin <12.0 g/dL as a reference value) or iron deficiency anemia (hemoglobin <12.0 g/dL and serum ferritin level less than 12ng/mL as reference values).
6.Patients aged 45 years old or younger after menarche.
Key exclusion criteria 1.Patients whose cause of abnormal bleeding is pregnancy bleeding.
2.Patients who have been diagnosed as VWD in the past.
3.Patients with an underlying disease that causes abnormal platelet function or who have been diagnosed with abnormal platelet function.
4.Patients receiving anticoagulant and/or antiplatelet agent
5.Patients who are pregnant at the time of obtaining consent
6.Patients with definite diagnosis of menorrhagia or dysmenorrhea with abnormal bleeding due to organic (e.g. endometrial polyps, adenomyosis, uterine leiomyoma, intrauterine malignancy, endometrial hyperplasia, etc.) or functional (e.g. ovulation disorder, endometrial dysfunction, etc.) gynecological diseases.
7.Others who are judged by the investigator or the subinvestigator to be inappropriate for participation in this study, such as those whose menorrhagia or dysmenorrhea with abnormal bleeding is clearly caused by a disease other than VWD.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Toshiro
Middle name
Last name Mizutani
Organization Mizutani-kai Medical Corporation Aiiku Ladies Clinic
Division name Executive Director
Zip code 274-0071
Address 5-8-16, Narashino, Funabashi, Chiba
TEL 047-476-1103
Email mizutani.bay.chiken@gmail.com

Public contact
Name of contact person
1st name Satoru
Middle name
Last name Enomoto
Organization Mebix, Inc.
Division name Research promotion division
Zip code 541-0046
Address 3-6-1, Hirano-cho, Chuo-ku, Oasaka, Osaka
TEL 06-6226-0657
Homepage URL
Email vwd-cra@mebix.co.jp

Sponsor
Institute Takeda Pharmaceutical Company Limited.
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yamauchi Clinic IRB
Address 1-15-19, Jiyugaoka, Meguro-Ku, Tokyo, Japan
Tel 03-5575-5862
Email c-irb_ug@neues.co.jp

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 医療法人社団 みずたに会 愛育レディースクリニック(千葉県)

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 26 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 Preinitiation
Date of protocol fixation
2021 Year 09 Month 30 Day
Date of IRB
2021 Year 11 Month 19 Day
Anticipated trial start date
2021 Year 12 Month 13 Day
Last follow-up date
2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2021 Year 11 Month 25 Day
Last modified on
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052498

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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