Dysmenorrhea
Conditions
Sponsors
MOCHIDA PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1)Patients who have a painful symptom (lower abdominal pain or lumber pain) that were considered to be originated in dysmenorrhea in a degree of 3 points or more of dysmenorrhea score (2)Patients diagnosed with dysmenorrhea (3)Regular menstrual cycle length within 38 days
Exclusion criteria
Exclusion criteria: (1)Patient with a complication of submucosal myoma (2)Patients with a complication of lower abdominal pain or lumber pain which they can not judge whether due to dysmenorrhea or not (3)Patients with a remarkable uterus swelling (4)Patients with undiagnosed abnormal genital bleeding, endometrial polyp, uterine deformity or endometrial hyperplasia (5)Patients with severe anemia etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Efficacy Change in dysmenorrhea score at primary evaluation period Safety Adverse effect after the initiation of medication Dysmenorrhea score | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Efficacy (1) Proportion of patients assessed as improved in dysmenorrhea score (2) Proportion of patients assessed as complete remission in dysmenorrhea score (3) Change in VAS score for lower abdominal pain or lumber pain Safety Adverse drug reaction after the initiation of medication Dysmenorrhea score, VAS | — |
Countries
Japan
Outcome results
None listed