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 range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.