CompletedPhase 2

Clinical Trial to Evaluate the Efficacy and Safety of DW4902

South Korea71 participantsStarted 2021-10-06

Plain-language 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.

Who can participate

Age range19 Years

SexFEMALE

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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.
✓. 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.

Exclusion criteria

✕. A person who is expected to perform the following surgical (procedure) history during the screening period or during the clinical trial period.
✕. 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.
✕. Subjects exhibiting any of the following test results during the screening period
✕. 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:
✕. Hypersensitivity or allergy to the components of the investigational drug.
✕. Hypersensitivity or allergy to hygiene products.

What they're measuring

Percentage of subjects with a total PBAC score

Timeframe: 6 to 12 week period since the baseline visit

Trial details

NCT IDNCT07319520

SponsorDaewon Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-11

View on ClinicalTrials.gov More Myoma of Uterus trials