Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea

A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea

A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients with Primary Dysmenorrhea

Inclusion Criteria:

• Female patients, age between 19 years to 44years
• Patients with menstrual pain over 4 out of 6 menstrual cycles before screening
• Patients with moderate or severe menstrual pain for recent 2 menstrual cycles
• Patients with regular menstrual cycles(28±7 days) for a year

Exclusion Criteria:

• Patients diagnosed or suspected of secondary dysmenorrhea
• Previous adverse reaction or known allergy to NSAIDs
• Breast feeding woman
• Patients who are not willing to use proper contraception during clinical trial period