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

UMIN ID: UMIN000046174

Registered date:26/11/2021

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Menorrhagia or dysmenorrhea with abnormal bleeding
• Date of first enrollment: 2021/12/13
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The proportion of patients with suspected VWD or other suspected coagulation abnormalities
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 45years-old
• Gender: Female
• Exclude 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.

Related Information

• Primary Sponsor: Takeda Pharmaceutical Company Limited.
• Source(s) of Monetary Support: Takeda Pharmaceutical Company Limited.