Adenomyosis
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 adenomyosis in a degree of 3 points or more of pain score (2) Patients diagnosed with adenomyosis by means of imaging analysis using both transvaginal sonography and magnetic resonance imaging
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed with either endometriosis or uterine leiomyoma using both transvaginal sonography and magnetic resonance imaging (2) Patients with a history or complication of severe anemia (hemoglobin less than 8.0 g/dL) due to adenomyosis (3) Patients with anemia (hemoglobin from 8.0 to just under 11.0 g/dL) showing insufficient restoration (hemoglobin less than 11.0 g/dL) after the treatment of anemia (4) Patients with a remarkable uterus swelling (100 mm or more in the greatest dimension or 40 mm or more in the maximal myometrial thickness) diagnosed by transvaginal sonography (5) Patient with undiagnosed abnormal genital bleeding, endometrial polyp, or endometrial hyperplasia etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Change in pain score at primary evaluation period Safety Adverse effect after the initiation of medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (1) Change in pain score at week 12 in the treatment period (2) Proportion of patients assessed as improved in pain score (3) Proportion of patients assessed as complete remission in pain score (4) Change in VAS score for painful symptom (lower abdominal pain or lumber pain) (5) Reduction in uterus size (6) Decrease in myometrial thickness Safety Adverse drug reaction after the initiation of medication | — |
Outcome results
None listed