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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT05026502
Eligibility Criteria:
Inclusion Criteria:
* Participants who have initiated elagolix + Estradiol/Norethindrone Acetate (E2/NETA) in the last 30 days or less, or with planned initiation of elagolix + E2/NETA prescribed as part of standard of care treatment.
* Participants self-reporting heavy menstrual bleeding (HMB) associated with uterine fibroids (UF).
* Participants are premenopausal (i.e., still report experiencing menses).
Exclusion Criteria:
* Participants that report they are pregnant or planning to become pregnant in next 6 months.
* Participants reporting a surgical history of:
* Hysterectomy (with or without oophorectomy).
* Bilateral oophorectomy.
* Participants who have initiated elagolix + E2/NETA more than 30 days ago.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
51 Years
Study:
NCT05026502
Study Brief:
Protocol Section:
NCT05026502