drugset / Trial / NCT05233956
Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya
Active not recruiting
405 enrolled
FHI 360
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-10-23
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | COCs | Unknown | 0.15 mg | Oral |
| Subject | Ferrous Sulfate | Diagnostic / imaging agent | 75 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 30 ug | Oral |