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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT05309694
Eligibility Criteria:
Inclusion Criteria:
* Subject is a postmenarcheal and premenopausal woman of child bearing potential.
* Subjects are at least 18 years of age, at the time of signing the informed consent.
* Subject is overtly healthy as determined by medical evaluation.
Exclusion Criteria:
* Pregnancy or suspicion of pregnancy or at risk for luteal phase pregnancy
* History of previous IUD complications
* Abnormalities of the uterus resulting in distortion of the uterine cavity that may complicate IUD insertion
* Known anatomical abnormalities of the cervix
* Presence of acute pelvic inflammatory disease at the time of screening.
* Postpartum endometritis.
* Known or suspected uterine or cervical malignancy.
* Uterine bleeding of unknown etiology.
* Untreated acute cervicitis or vaginitis or other lower genital tract infection.
* Conditions associated with increased susceptibility to pelvic infections.
* Subjects with Wilson's disease.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05309694
Study Brief:
Protocol Section:
NCT05309694