Functional 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 functional dysmenorrhea in a degree of 3 points or more of dysmenorrhea score (2) Patients diagnosed with functional dysmenorrhea by means of transvaginal sonography and pelvic examination (3) Regular menstrual cycle length within 38 days
Exclusion criteria
Exclusion criteria: (1) Patients with a history of either endometriosis, uterine leiomyoma, adenomyosis or secondary dysmenorrhea (2) Patients with a complication of nonmenstrual painful syndrome (lower abdominal pain or lumber pain) (3) Patients with severe or moderate anemia (hemoglobin less than 10.0 g/dL) (4) Patient with undiagnosed abnormal genital bleeding, endometrial polyp, or endometrial hyperplasia (5) Patients with a complication or history of thrombosis, embolism, cerebrovascular disorder or coronary artery disease. Patients with a predisposing factor of thrombosis. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Change in dysmenorrhea score at primary evaluation period Safety Adverse effect after the initiation of medication Dysmenorrhea score | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (1) Change in dysmenorrhea score at week 4 and 8 in the treatment period (2) Proportion of patients assessed as complete remission in dysmenorrhea score (3) Change in VAS score for painful symptom (lower abdominal pain or lumber pain) Safety Adverse drug reaction after the initiation of medication Dysmenorrhea score, VAS | — |
Outcome results
None listed