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NCT05233956Not yet recruiting

Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya

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
FHI 360ClinicalTrials.govdiagnostic test
Verified
Study focus
Disease/Condition
Anemia
Drug/Device/Intervention
Measure hemoglobin
Study type
Interventional
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
FHI 360
Timeline & enrollment
Phase
N/A
Start date
Sep 01, 2023
End date
Feb 01, 2026
Enrollment
600 participants
Primary outcome

Change in hemoglobin

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 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

ICD-10 classifications
Anaemia, unspecifiedOther anaemiasOther specified anaemiasIron deficiency anaemiaIron deficiency anaemia, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05233956
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05233956 through Pure Global AI's free database. This phase not specified trial is sponsored by FHI 360 and is currently Not yet recruiting. The study focuses on Anemia. Target enrollment is 600 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.