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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT06577168
Eligibility Criteria:
Inclusion Criteria:
* Included participants with normal regular menses prior to LNG-IUS
insertion
* Included participants of any age, race, ethnicity, or parity
* Contained bleeding and/or spotting data on the 52 mg (20 mg/d) LNG-IUS
* Collected daily menstrual bleeding data from written diaries for at least 90 consecutive days
Exclusion Criteria:
* Heavy or prolonged menstrual bleeding (menorrhagia)
* Actively breastfeeding
* Hormonal long-acting reversible contraceptive method (LNG-IUS, implant) within 3 months of enrollment
* Hormonal injectable contraceptive use within 6 months of enrollment
* First 3 months (90 days) of data from women with postpartum or postabortion LNG-IUS insertions
* Any anatomical or pathological condition (ie, uterine fibroids) that may have an impact on baseline menstrual bleeding pattern
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06577168
Study Brief:
Protocol Section:
NCT06577168