Clinical Trial to Evaluate the Efficacy and Safety of DW4902

NCT07319520 | Completed Phase 2

• 1 other identifier: DW4902-201
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with a total PBAC score

  Percentage of subjects with a total PBAC score of less than 10 points in the 6 to 12 week period since the baseline visit

  6 to 12 week period since the baseline visit

Secondary Outcomes (10)

• Percentage of subjects with a total PBAC score

  2 to 6 week period since the baseline visit.

• Percentage of subjects with a total PBAC score

  8 to 12 week period since the baseline visit.

• Percentage of subjects with a total PBAC score

  12-week visit point after dosing

• Percentage of subjects for amenorrhea

  6 to 12 week period after the baseline visit

• Percentage of subjects for amenorrhea

  2 to 6 week period after the baseline visit

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo 4 capsules

Drug: DW4902 Placebo

Low-Dose

EXPERIMENTAL

DW4902 80mg 2 capsules , Placebo 2 capsules

Drug: DW4902 160mg

Medium-Dose

EXPERIMENTAL

DW4902 80mg 3 capsules , Placebo 1 capsules

Drug: DW4902 240mg

High-Dose

EXPERIMENTAL

DW4902 80mg 4 capsules

Drug: DW4902 320mg

Interventions

DW4902 Placebo DRUG

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)

Placebo

DW4902 160mg DRUG

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)

Low-Dose

DW4902 240mg DRUG

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)

Medium-Dose

DW4902 320mg DRUG

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)

High-Dose

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- \[For Subjects Requiring a Run-in Period\]
• Premenopausal women aged 19 years or older.
• Subjects diagnosed with uterine fibroids prior to screening, based on imaging studies.
• At least one uterine fibroid with a longest diameter (D1) ≥3 cm confirmed by transvaginal ultrasound at Screening Visit 1.
• History or symptoms of heavy menstrual bleeding (HMB) due to uterine fibroids, confirmed prior to screening.
• Subject agrees to comply with the following contraceptive methods and restrictions during the clinical trial.
• Subject agrees to use the sanitary products provided during the clinical trial.
• Subject has voluntarily consented to participate in this clinical trial and signed the informed consent form.
• Prior to Screening Visit 2, the subject has had at least two regular menstrual cycles with menstruation lasting at least three consecutive days in each cycle.
• Subject, in the investigator's clinical judgment, is determined to have symptoms of heavy menstrual bleeding (HMB) due to uterine fibroids, requiring medication.
• During the screening period, the subject has had regular menstrual cycles with menstruation lasting at least three consecutive days in each cycle.
• During the screening cycle (Pre-C), a PBAC assessment score of 120 or higher is confirmed.
• \[For Subjects Not Requiring a Run-in Period\]
• <!-- -->
• Premenopausal women aged 19 years or older.

You may not qualify if:

• A subject who meets any of the following criteria will be excluded from participation in this clinical trial.
• A person who is expected to perform the following surgical (procedure) history during the screening period or during the clinical trial period.
• ① Surgery (procedure) history of uterine fibroids within 24 weeks prior to participation in screening.
• : myomectomy, high intensity focused ultrasound, uterine artery embolization etc.
• ② hysterectomy, ovarian resection, endometrial ablation.
• ③ Surgery that may affect gastrointestinal absorption of clinical trial drugs. However, simple appendectomy and hernia surgery can be participated.
• As a result of imaging examination at the time of screening (ultrasound, etc.), a person identified as having a gynecological disorder evaluated clinically significant by the examiner other than uterine myoma.
• During the screening period, the following medical history or comorbidities are identified.
• Endometriosis or symptomatic dominant adenomyosis.
• Anovulatory bleeding, non-diagnostic abnormal uterine bleeding, or non-diagnostic abnormal genital bleeding.
• Lower abdominal pain or pelvic inflammatory disease due to trauma or a condition other than uterine fibroids (e.g., irritable bowel syndrome, interstitial cystitis, etc.) within 12 weeks prior to screening participation.
• Metabolic bone disease, including osteoporosis.
• Thyroid/parathyroid disease (e.g., hyperthyroidism, hyperparathyroidism), hyperprolactinemia, anorexia nervosa, which contributes to bone mineral density loss, within 24 weeks prior to screening participation.
• Any malignancy, including gynecologic cancer, within 5 years prior to screening participation. However, skin basal cell carcinoma/polarized cell carcinoma/microthyroid papillary carcinoma can participate after successful treatment.
• Type 1 diabetes or uncontrolled type 2 diabetes.

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Study Officials

• Sunghoon Kim

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: October 6, 2021
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)