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:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT03317795
Eligibility Criteria:
Inclusion Criteria:
* Premenopausal women ages 25 -50
* Monthly menses
* Image-confirmed uterine fibroids of at least 1 cm in size, either submucosal or intramural
* Seeking treatment for heavy menstrual bleeding following completed clinical evaluation
* Self-reported heavy menstrual bleeding for three months or longer
* Completed evaluation for heavy menstrual bleeding within one year of study enrollment
* Understands the English language for consent and questionnaires
* Able and willing to provide informed consent
Exclusion Criteria:
* Class 0 fibroids confirmed by hysteroscopy, saline-infused sonogram, or 3D ultrasound
* Uterine sounding length ≥ 14 cm
* Uterine size ≥ 20 weeks gestational size
* Abnormal endometrial biopsy or incomplete clinical testing to rule out malignancy
* Needs or is using hormonal contraception, including estrogen-containing medications
* Venous thromboembolic history, clotting disorder, or strong family history of venous thromboembolic events
* Breast, uterine, or cervical malignancy
* Liver disease or liver tumor
* Pelvic inflammatory disease, gonorrhea or chlamydia infection during the past three months
* Hemoglobin \< 8 mg/dL. For women with hemoglobin 8.0 - 12.0 mg/dL, iron supplement is recommended
* Serum creatinine ≥ 1.4
* Current pregnancy or currently lactating
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
50 Years
Study:
NCT03317795
Study Brief:
Protocol Section:
NCT03317795