UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046174 |
|---|---|
| Receipt number | 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 | 2022/11/30 08:13:57 |
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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 | Obstetrics 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
President
Zip code
274-0071
Address
5-8-16, Narashino, Funabashi, Chiba
TEL
047-476-1103
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
vwd-cra@mebix.co.jp
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
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
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）、医療法人社団清雅会Shimizu Maternity Clinic（東京都）、医療法人社団三世会 大高医院（千葉県）、医療法人創起会くまもと森都総合病院（熊本県）、独立行政法人国立病院機構金沢医療センター（石川県）、富山県立中央病院（富山県）、静岡赤十字病院（静岡県）、焼津市立総合病院（静岡県）、医療法人社団聖順会ジュノ・ヴェスタクリニック八田（千葉県）、医療法人社団誠仁メディカル誠ウィメンズクリニック（東京都）、社会医療法人社団カレスサッポロ時計台記念病院（北海道）、医療法人社団ゆかり会虎ノ門ウィメンズクリニック（東京都）
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
No longer recruiting
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
| 2022 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052498
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