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Myoma of UterusPhase 2NCT07319520

Clinical Trial to Evaluate the Efficacy and Safety of DW4902

A Phase 2 study testing DW4902 160mg, DW4902 240mg and DW4902 320mg in people with Myoma of Uterus, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Myoma of Uterus
What is being tested?
DW4902 160mg, DW4902 240mg and DW4902 320mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
71 participants
Where
1 siteSouth Korea
Study dates
6 Oct 2021to 11 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • [For Subjects Requiring a Run-in Period]
  • Screening Visit 1 (Visit 1) Inclusion Criteria
  • 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.
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  • 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.
  • Screening Visit 2 (Visit 2) Inclusion Criteria
  • 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.
  • Baseline Visit (Visit 3) Inclusion Criteria
  • 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]
  • Screening Visit 2 (Visit 2) Inclusion Criteria
  • <!-- -->
  • Premenopausal women aged 19 years or older.
  • Subjects diagnosed with uterine fibroids prior to screening via imaging , and at least one uterine fibroid with a longest diameter (D1) ≥3 cm confirmed by transvaginal ultrasound at Screening Visit 2.
  • Subject, in the investigator's clinical judgment, is determined to have symptoms of heavy menstrual bleeding (HMB) due to uterine fibroids, requiring medication.
  • Within 3 months prior to screening, the subject has had regular menstrual cycles with menstruation lasting at least three consecutive days in each cycle.
  • 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.
  • Baseline Visit (Visit 3) Inclusion Criteria
  • 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), PBAC assessment score of 120 or higher is assessed.

Who cannot join

  • 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.
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  • 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.
  • Major cardiovascular disease within 24 weeks prior to screening.
  • Severe cardiac disease (heart failure (NYHA class 3 and 4), acute coronary artery disease (unstable angina, acute myocardial infarction), clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmias deemed clinically significant by the investigator, and peripheral vascular disease.
  • Hypertrophic obstructive cardiomyopathy, clinically significant valvular heart disease, or aortic disease, etc.
  • Blood disorders. However, those with iron-deficiency anemia are eligible for participation.
  • thalassemia, sickle cell anemia, folic acid deficiency, coagulopathy. etc. ⑩ Gastrointestinal diseases that may affect the gastrointestinal absorption of the investigational drug at the time of screening ⑪ Active hepatitis B or active hepatitis C at the time of screening ⑫ History of HIV (human immunodeficiency virus) infection ⑬ History of major psychiatric disorders (such as depression, bipolar disorder), or history of substance/alcohol abuse
  • Subjects exhibiting any of the following test results during the screening period
  • Hemoglobin (Hb) < 8 g/dL (Grade 3 anemia according to CTCAE ver. 5.0)
  • Bone mineral density test (dual energy x-ray absorptiometry, DXA): Z-score ≤ -1.5 in the lumbar spine, total hip, or femoral neck
  • QTc interval > 480 msec* (Grade 2 according to CTCAE ver. 5.0)
  • Fridericia's QT correction formula ④ AST or ALT > 3 x ULN (Grade 2 according to CTCAE ver. 5.0)
  • ⑤ Creatinine > 1.5 x ULN (Grade 2 according to CTCAE ver. 5.0)
  • ⑥ Uncontrolled hypertension (sitSBP ≥ 160 mmHg or sitDBP ≥ 100 mmHg; Grade 3 according to CTCAE ver. 5.0)
  • ⑦ Clinically significant abnormal pathological findings in endometrial biopsy
  • ⑧ Positive result from PAP smear test
  • according to Bethesda system >NILM (negative for intraepithelial lesion or malignancy)
  • Pregnant or lactating women during the screening period
  • Subjects with a history of administering or expected to administer the following medications during the clinical trial:
  • ① Use of the following medications within 12 weeks prior to Screening Visit 2, or use of hormonal contraceptives within 8 weeks prior to Visit 2(including estrogen/progesterone supplements)/hormonal intrauterine device. However, for medroxy progesterone acetate injection depot formulations and Leuprorelin depot 22.5 mg, 30 mg, or 45 mg, administration within 24 weeks prior to Screening Visit 2 must be confirmed.
  • GnRH agonists (e.g., Leuprorelin depot 11.25 mg), GnRH antagonists, selective estrogen receptor modulators, progesterone receptor modulators, anti-gonadotropins, gonadotropin-releasing hormones, aromatase inhibitors, anti-estrogens, prolactin inhibitors, spironolactone, etc. However, administration of Leuprorelin depot 3.75 mg within 4 weeks prior to the screening visit constitutes an exclusion criterion.
  • Use of therapeutic agents for metabolic bone diseases within 12 weeks prior to Screening Visit 2.
  • Use of anticoagulants, antiplatelet agents, or low-dose aspirin within 4 weeks prior to Screening Visit 2
  • Use of antifibrinolytic agents within 4 weeks prior to Screening Visit 2 ⑤ Use of analgesics other than ibuprofen during the clinical trial ⑥ Systemic corticosteroids administered for 14 days or more within 12 weeks prior to Screening Visit 2 ⑦ Strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) within 4 weeks prior to Screening Visit 2 ⑧ Strong inducers or inhibitors of P-glycoprotein (P-gp) within 4 weeks prior to Screening Visit 2
  • Hypersensitivity or allergy to the components of the investigational drug.
  • Hypersensitivity or allergy to hygiene products.
  • Individuals for whom the gynecological examinations required by the study are considered difficult or impossible to perform.
  • Individuals who have participated in other clinical trial and received investigational drugs or investigational medical devices within 4 weeks prior to screening.
  • Individuals otherwise deemed unsuitable for participation in the clinical trial by the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: 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

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
Being tested
DW4902 Placebo, DW4902 160mg, DW4902 240mg, DW4902 320mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DW4902 PlaceboDrug

    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)

  • DW4902 160mgDrug

    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)

  • DW4902 240mgDrug

    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)

  • DW4902 320mgDrug

    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)

Study groups in NCT07319520
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo 4 capsules
Receives: Drug: DW4902 Placebo
Low-DoseExperimentalDW4902 80mg 2 capsules , Placebo 2 capsules
Receives: Drug: DW4902 160mg
Medium-DoseExperimentalDW4902 80mg 3 capsules , Placebo 1 capsules
Receives: Drug: DW4902 240mg
High-DoseExperimentalDW4902 80mg 4 capsules
Receives: Drug: DW4902 320mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 to 12 week period since the baseline visit

Secondary outcomes (10)

  1. Percentage of subjects with a total PBAC score

    Percentage of subjects with a total PBAC score of less than 10 points in the 2 to 6 week period since the baseline visit.

    Measured: 2 to 6 week period since the baseline visit.

  2. Percentage of subjects with a total PBAC score

    Percentage of subjects with a total PBAC score of less than 10 points in the 8 to 12 week period since the baseline visit.

    Measured: 8 to 12 week period since the baseline visit.

  3. Percentage of subjects with a total PBAC score

    Percentage of subjects with a total PBAC score of less than 10 points in the previous recent menstrual cycle, as of the 12-week visit point after dosing

    Measured: 12-week visit point after dosing

  4. Percentage of subjects for amenorrhea

    Percentage of subjects for amenorrhea during the 6 to 12 week period after the baseline visit

    Measured: 6 to 12 week period after the baseline visit

  5. Percentage of subjects for amenorrhea

    Percentage of subjects for amenorrhea during the 2 to 6 week period after the baseline visit

    Measured: 2 to 6 week period after the baseline visit

  6. Changes in hemoglobin levels (g/dL)

    Changes in hemoglobin levels (g/dL) at 8 weeks and 12 weeks after dosing compared to baseline visits

    Measured: 8 weeks and 12 weeks after dosing compared to baseline visits

  7. The proportion of subjects whose hemoglobin level increased by >2 g/dL

    Among subjects with a hemoglobin level ≤10.5 g/dL at the baseline visit, the proportion of subjects whose hemoglobin level increased by >2 g/dL at the 8-week and 12-week visits compared to the baseline visit

    Measured: 8 week and 12 week visits compared to the baseline visit

  8. Changes and rates of change in uterine fibroid size

    Changes and rates of change in uterine fibroid size at the 12-week visit after dosing compared to the baseline visit

    Measured: 12 week visit after dosing compared to the baseline visit

  9. Changes and rates of change in uterine size

    Changes and rates of change in uterine size at the 12-week visit after dosing compared to the baseline visit

    Measured: 12 week visit after dosing compared to the baseline visit

  10. The proportion of subjects with a uterine fibroid-associated peak NRS pain score

    Among subjects with a uterine fibroid-associated peak NRS pain score of ≥4 during the menstrual cycle (Pre-C) of the screening period, the proportion of subjects with a uterine fibroid-associated peak NRS pain score of ≤1 during the 6 to 12 week period after the baseline visit

    Measured: 6 to 12 week period after the baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start6 Oct 2021
  3. Primary completion11 Nov 2024
  4. Study completion11 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07319520
Sponsor's protocol ID
DW4902-201
Status last verified
Jan 2026
First submitted
22 Dec 2025
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DW4902 160mg, DW4902 240mg and DW4902 320mg in people with Myoma of Uterus, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with a total PBAC score (time frame: 6 to 12 week period since the baseline visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07319520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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