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 @ 1:56 PM
Ignite Modification Date:
2025-12-24 @ 1:56 PM
NCT ID:
NCT03493295
Eligibility Criteria:
Inclusion Criteria:
* Women in childbearing age, between 18-30 years old.
* Women who have chosen a LNG-IUS as contraceptive method, after been adequately counselled by the physician about all contraceptive possible options.
* Women who have chosen a LNG-IUS mainly for contraceptive reasons, not due to heavy menstrual bleeding.
* Women with no desire to conceive for at least within the next 12 months.
* Women capable of reading and writing
Exclusion Criteria:
* Women whose main reason to use a LNG-IUS is not a contraceptive reason.
* Women with contraindication for LNG-IUS.
* Women with previous experience with a IUS.
* Women who have been diagnosed with heavy menstrual bleeding.
* Women with degenerative or other kind of diseases that could directly negatively impact their daily life.
* Women who have undergone a hysterectomy or irreversible contraceptive method.
* Women participating in a clinical trial.
* Women with a mental illness and unable to make decisions and follow instructions.
* Women with amenorrhea
* Women with clinical history of severe dysmenorrhea
* Women with concomitant medication that may lead changes in bleeding pattern (e.g. antiplatelets and/or anticoagulants)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT03493295
Study Brief:
Protocol Section:
NCT03493295