Clinical Trial to Evaluate the Efficacy and Safety of DW4902 (NCT07319520) | Clinical Trial Compass
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 range
19 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects with a total PBAC score
Timeframe: 6 to 12 week period since the baseline visit
. 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.