Primary Dysmenorrhea
Conditions
Brief 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
Interventions
Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)
DRUGPlacebo
Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TOTPAR-8 | Day 1 | Time weighted sum of total pain relief |
| SPID-8 | Day 1 | Sum of pain intensity difference |
Outcome results
None listed