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

Daewon Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Primary Dysmenorrhea

Treatments: Drug: Pelubiprofen 45mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04541134

DW9801-303

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: Female

Ages: 19 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Group 1

Other group

Treatment:

Drug: Placebo

Drug: Pelubiprofen 45mg

Group 2

Other group

Treatment:

Drug: Placebo

Drug: Pelubiprofen 45mg