Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in… (NCT05233956) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya
Kenya405 participantsStarted 2023-10-23
Plain-language summary
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 12-18 months. Approximately 400 participants will be enrolled. The primary hypothesis that the mean change in hemoglobin in the group assigned to the LNG IUS will be superior to the COC/ferrous fumarate (control) group after 12-months of product use.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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