NCT04541134 is a Phase 3 clinical trial of Pelubiprofen 45mg in Primary Dysmenorrhea, sponsored by Daewon Pharmaceutical Co., Ltd..

Who is sponsoring NCT04541134?

NCT04541134 is sponsored by Daewon Pharmaceutical Co., Ltd..

What drugs are being tested in NCT04541134?

Interventions in NCT04541134: Pelubiprofen 45mg, Placebo.

What condition does NCT04541134 study?

NCT04541134 studies Primary Dysmenorrhea.

Is NCT04541134 still recruiting?

NCT04541134 is currently status unknown. Last updated 9 September 2020.

Last reviewed 2020-09-09 · How we verify

NCT04541134

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 3 Last updated 9 September 2020

What this trial tests

Phase 3 trial testing Pelubiprofen 45mg in Primary Dysmenorrhea in 120 participants. Status unknown.

Timeline

30 September 2020

Primary endpoint
30 August 2021

30 August 2021

Quick facts

Lead sponsor	Daewon Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	120
Start date	30 September 2020
Primary completion	30 August 2021
Estimated completion	30 August 2021

Drugs / interventions tested

Pelubiprofen 45mg — full drug profile →
Placebo

Conditions studied

Primary Dysmenorrhea — all drugs for Primary Dysmenorrhea →

Sponsor

Daewon Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 19 to 44, female only, with Primary Dysmenorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and Safety of Pelubiprofen for Primary Dysmenorrhea: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Trial.
Park JH, Lee I, Choo SP, Lee JH, et al · · 2026 · PMID 41976959 · DOI 10.3390/jcm15072658

Verify or expand the search:

Other recruiting trials for Primary Dysmenorrhea

Currently open trials in the same condition.

NCT07409337 — Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms · NA · recruiting
NCT06995287 — Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysme · Phase 3 · recruiting
NCT07352982 — Transcutaneous Tibial Nerve Stimulation on Women With Primary Dysmenorrhea · NA · recruiting
NCT07239232 — "Knee Joint Position Sense and Dynamic Balance in Females With Primary Dysmenorrhea · recruiting
NCT07314021 — Primary Dysmenorrhea and Mobilization. · NA · active not recruiting

Other Daewon Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07364851 — A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DW4421-T1 and DW4421S-T1 in Healthy Adult Volunt · Phase 1 · not yet recruiting
NCT07349589 — Evaluate the Safety, Tolerability and Pharmacokinetics of DW5524 in Healthy Adult Volunteers · Phase 1 · not yet recruiting
NCT07364877 — A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DW4421 and DW4421S in Healthy Adult Volunteers · Phase 1 · enrolling by invitation
NCT07343245 — A Phase 1 Clinical Trial to Evaluate the Safety and DDI of DW4421 and 3 NSAIDs · Phase 1 · recruiting
NCT07319559 — Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics of DW5124 and DW5124-R, and the Effect of Food on · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04541134 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Daewon Pharmaceutical Co., Ltd.
Last refreshed: 9 September 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04541134.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing