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

• Status: Not yet recruiting
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Criteria

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