Menorrhagia or dysmenorrhea with abnormal bleeding
Conditions
Interventions
None listed
Sponsors
Takeda Pharmaceutical Company Limited.
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with suspected VWD or other suspected coagulation abnormalities | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactSatoru Enomoto
Mebix, Inc. Research promotion division
Outcome results
None listed