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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

Not Applicable
Conditions
Menorrhagia or dysmenorrhea with abnormal bleeding
Registration Number
JPRN-UMIN000046174
Lead Sponsor
Takeda Pharmaceutical Company Limited.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
Female
Target Recruitment
100
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The proportion of patients with suspected VWD or other suspected coagulation abnormalities
Secondary Outcome Measures
NameTimeMethod
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.
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