An interventional study of LNG IUS and COCs in Anemia, sponsored by FHI 360. Active, not recruiting at 1 site in Kenya. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by FHI 360 · Not applicable, Interventional, and Treatment
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.
Anemia continues to disproportionately affect marginalized women in resource-poor countries. In Africa/SE Asia, over 270 million women of reproductive age are anemic. Iron deficiency anemia causes 18% of maternal deaths worldwide. Multiprong approaches are needed to reduce the prevalence of anemia and the negative impact on family health.
Every menstrual cycle, women lose 14 to 19 mg of iron; this is iron that anemic women need to lead healthier lives. Though the relationships between iron loss from menstruation, absorption of dietary intake of iron, storing iron, and the impacts on hematologic parameters are complex, higher levels of menstrual blood loss are associated with lower hemoglobin values.
The levonorgestrel intrauterine system is a highly effective contraceptive product that also generally reduces menstrual blood loss. In research spanning over four decades, the product consistently raises hemoglobin levels and increases iron stores in broad populations of women, but particularly for women with heavy menstrual bleeding. This product is not widely available in resource-poor countries, due to higher costs relative to other contraceptives.
As a potential tool to alleviate anemia, the levonorgestrel intrauterine system has never been adequately tested. Previous research has never focused on anemic women, nor used proper scientific approaches to determine if the product can significantly increase hemoglobin and iron levels via reducing menstrual blood loss.
The overall goal of the proposed research is to give anemic women in Kenya an opportunity to try the levonorgestrel intrauterine system and with improved scientific approaches, measure the impact on hemoglobin and iron stores. In this randomized trial, the comparison product will be oral contraceptives containing iron supplement pills. If the levonorgestrel intrauterine system is found to work as hypothesized, then the product can become another tool to alleviate anemia among reproductive-aged women, resulting in healthier living and healthier beginnings to pregnancy when desired.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 405 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →FHI 360 is the lead sponsor of 56 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Levonorgestrel intrauterine system
Device: LNG IUS
Combined oral contraceptives with ferrous fumarate tablets in regimen
Drug: COCs
Avibela®: Levonorgestrel intrauterine system (LNG IUS) containing 52mg of LNG, released in the uterine cavity at approximately 19mcg per day.
FemiplanTM: Combined oral contraceptives in a 21/7 pill package (21 pills of 0.15 mg of LNG and 30 mcg of EE followed by 7 pills containing 75 mg of ferrous fumarate).
Hemoglobin Level
Measured in g/L
Time frame: 12 months
Serum ferritin Level
Measured in mcg/L
Time frame: 18 months
Volume of menstrual blood loss and quantity of hygiene products used
Self-report
Time frame: 3, 6, 9, 12, 15, and 18 months
Severe Anemia
Venous hemoglobin less than 86g/L
Time frame: At 6,12 and 18 months
Contraceptive satisfaction
Level of satisfaction with the products will be recorded on a 5-point Likert scale: very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied.
Time frame: 12-18 months
Hemoglobin Changes
g/L
Time frame: 18 months
Plan to share: Yes — Data generated under the project will be shared consistent with the NIH Grant Policy, and the FHI 360 Protection of Human Subjects (PHSC) committee guidelines. Data will be de-identified to avoid linkages to individual research participants and will be free of variables that could lead to deductive disclosure of the identity of individual research participants. A de-identified primary dataset will be posted to an open-data repository within 30 calendar days after the first publication.
Supporting information: Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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