Dysmenorrhea
Conditions
Interventions
MD-352 at A dose, at B dose or placebo is administered orally.
Sponsors
Mori Takuya
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: -Patients diagnosed with primary dysmenorrhea or secondary dysmenorrhea. -Patients whose last two menstrual cycles prior to randomization enrollment each fall within a range of 30+/-5 days. -Patients who have a degree of 3 points or more of dysmenorrhea score during the menstrual cycle of the screening period.
Exclusion criteria
Exclusion criteria: -Patients with a complication of lower abdominal pain or lumber pain the cause of which can not be ruled out as dysmenorrhea. -Patients with a complication or history of thrombophlebitis, pulmonary embolism, cerebral vascular disorder or coronary artery disease. Patients with a predisposing factor of thrombosis. -Patients who are pregnant or possibly pregnant or nursing mother, or patients who cannot comply with contraception during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Change in dysmenorrhea score Safety: Adverse events Genital haemorrhage | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Change in VAS score for painful symptom (lower abdominal pain or lumber pain) Changes in pelvic pain (lower abdominal pain or lumber pain) score Safety: Adverse drug reactions | — |
Contacts
Public ContactPublic relations
Mochida Pharmaceutical Co., Ltd.
Outcome results
None listed