Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya: an Open Label Randomized Trial to Compare With an Oral Contraceptive Regimen That Provides Supplemental Ferrous Fumarate Tablets

1712233

Women with mild/moderate anemia who are seeking contraception will be randomized to a levonorgestrel (LNG) intrauterine system (IUS) or an LNG/ethinyl estradiol (EE)/ferrous fumarate combined oral contraceptive (COC) regimen and followed prospectively for 18 months. Approximately 600 participants will be enrolled. The primary hypothesis is that the mean change in hemoglobin concentration will be significantly higher in the group assigned to the LNG IUS compared to the group assigned to COCs

2023-10-23

2026-02-01

2026-02-01

Recruiting

600

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

2024-05-31