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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT02147158
Eligibility Criteria:
Inclusion Criteria:
* Premenopausal women, 18-50 years, inclusive.
* Cyclic abnormal uterine bleeding (heavy or prolonged).
* Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.
* Minimum of one discrete leiomyoma observable by transvaginal ultrasound.
* Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia.
Exclusion Criteria:
* History of uterine surgery that would interfere with the study endpoints.
* Known coagulation disorder including bleeding disorder or clotting disorder.
* History of, or current uterine, cervix, ovarian, or breast cancer.
* Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal range.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02147158
Study Brief:
Protocol Section:
NCT02147158