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

NCT04541134 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-09-09

No results posted yet for this study

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

Conditions

  • Primary Dysmenorrhea

Interventions

DRUG

Pelubiprofen 45mg

Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)

DRUG

Placebo

Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)

Sponsors & Collaborators

  • Daewon Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2021-08-30
Completion
2021-08-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04541134 on ClinicalTrials.gov