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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT05233956
Eligibility Criteria:
Inclusion Criteria:
* Provide sequential oral and written consents to screen for eligibility and enroll
* Female, aged 18-50
* Desire to use contraception or possibly switch methods
* Possession of a cell phone and willingness to be contacted
* Confirmatory low hemoglobin (minimum of 87 g/L and maximum of 126 g/L) taken 1 to 4 weeks after the initial test
* Regularly menstruating (at least once every 35 days)
* At least 6 weeks postpartum
* Willingness to agree to study procedures
* Willingness to be randomized to treatment
* Willingness to use assigned hormonal contraceptive for 18 months
Exclusion Criteria:
* Severe anemia (hemoglobin \< 86 g/L)
* Currently pregnant based on urine pregnancy test and failure to rule out possible pregnancy according to WHO guidelines
* Surgically sterilized or had a hysterectomy
* Participated previously in this study by being randomized to contraceptive
* Currently using a subdermal contraceptive implant and does not wish to have it removed
* Currently using an LNG IUS
* Currently receiving treatment for anemia
* Any of the following previously diagnosed disorders: hemosiderosis, hemochromatosis, hemolytic anemia
* Known allergic reactions to oral contraceptives or LNG IUS
* Currently receiving an investigational (unapproved) drug in another study
* Any condition (social or medical) which in the opinion of the investigator would make study participation unsafe
* Intending to become pregnant in the next 18 months
* Mucopurulent cervicitis
* Pelvic inflammatory disease
* Other medical contraindications to treatment, according to WHO Medical Eligibility Criteria (categories 3 or 4)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05233956
Study Brief:
Protocol Section:
NCT05233956