Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07402369
Eligibility Criteria:
Inclusion Criteria:
* 1.Non-menopausal females aged 18-50 years.
* 2\. Body Mass Index (BMI) ≥ 18 kg/m².
* 3\. Participant was diagnosed with uterine fibroids by ultrasound at the time of screening, and has one or more fibroids with a diameter of at least 2 cm (longest diameter).
* 4\. Participant's menstrual cycle was ≥ 21 days and ≤ 35 days for the three consecutive months prior to screening, and the menstrual period was ≤ 14 days.
* 5\. Menorrhagia due to uterine fibroids.
* 6\. Agrees to use the contraceptive method specified in the protocol throughout the entire study period (from signing the informed consent form to 6 months after administration of the investigational drug).
Exclusion Criteria:
* 1\. Pregnant or breastfeeding female
* 2\. History of childbirth within 6 months prior to screening
* 3\. Excessive menstrual bleeding due to other causes or unknown reasons
* 4\. Suffering from a severe coagulation disorder (e.g., hemophilia or von Willebrand disease)
* 5\. Underwent myomectomy, endometrial ablation, uterine artery embolization, or magnetic resonance-guided focused ultrasound (MRgFUS)/high-intensity focused ultrasound (HIFUS) ablation within 6 months prior to screening
* 6\. Underwent endometrial ablation within one year prior to screening
* 7\. Severe infection, severe trauma, or major surgery within the 6 months prior to screening.
* 8\. History of malignant tumors within the 5 years prior to screening (excluding cured skin cancer, basal cell carcinoma, and other localized malignant tumors).
* 9\. Current or past (within 1 year) history of alcohol or drug abuse (including analgesic abuse).
* 10\. Currently participating in other research projects and having used the investigational drug/treatment within 12 weeks prior to administration.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07402369
Study Brief:
Protocol Section:
NCT07402369