NCT07319520

Clinical Trial to Evaluate the Efficacy and Safety of DW4902

A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DW4902 in Patients With Uterine Fibroids

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Daewon Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

A Multi-center, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of DW4902 in Patients with Uterine Fibroids.

Conditions

• Myoma of Uterus

Interventions

Type	Name	Description
DRUG	DW4902 Placebo	Starting from the Baseline Visit (Visit 3), administer orally once daily at a dose of 4 capsules before meals for 12 weeks. (Placebo 4 capsules)
DRUG	DW4902 160mg	Starting from the Baseline Visit (Visit 3), administer orally once daily at a dose of 4 capsules before meals for 12 weeks.. (DW4902 80mg 2 capsules , Placebo 2 capsules)
DRUG	DW4902 240mg	Starting from the Baseline Visit (Visit 3), administer orally once daily at a dose of 4 capsules before meals for 12 weeks.. (DW4902 80mg 3 capsules , Placebo 1 capsules)
DRUG	DW4902 320mg	Starting from the Baseline Visit (Visit 3), administer orally once daily at a dose of 4 capsules before meals for 12 weeks.. (DW4902 80mg 4 capsules)

Timeline

• Start date: 2021-10-06
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2026-01-06
• Last updated: 2026-01-07

Locations

1 site across 1 country: South Korea