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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03328260
Eligibility Criteria:
Inclusion Criteria:
* Premenopausal (FSH \< 40 IU/L)
* Symptomatic uterine fibroids
* Willing to contracept during study period
Exclusion Criteria:
* Pregnant or willing to be pregnant in future
* Cancer in female reproductive organ is suspected or diagnosed
* Inflammation in female reproductive organ
* Poorly controlled systemic disease
* Hematocrit \< 25%
* Glomerular filtration rate(GFR) \<= 30ml/min
* Cannot tolerate contrast-enhanced MR or Contrast-enhanced ultrasound(CEUS)
* Cannot lie down
* Previous treatment for leiomyoma, any of ① myolysis, ② myomectomy within 1 year, ③ hormonal therapy longer than 7 days within 4 weeks
* Cannot count the number or measure volume of leiomyoma using MRI
* Leiomyomas are inadequate (location, volume, number) for intervention
* Diameter of leiomyoma is over 5 cm
* Leiomyoma is not enhanced
* Lactating women
* Cannot communicate properly
* Participating or have participated in other trials within 30 days
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
19 Years
Study:
NCT03328260
Study Brief:
Protocol Section:
NCT03328260