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Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya - Trial NCT05233956

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.

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NCT05233956
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diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT05233956
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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

Study Focus

Anemia

Measure hemoglobin

Interventional

diagnostic test

Sponsor & Location

FHI 360

Timeline & Enrollment

N/A

Sep 01, 2023

Feb 01, 2026

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, unspecified
Other anaemias
Other specified anaemias
Iron deficiency anaemia
Iron deficiency anaemia, unspecified

Data Source

ClinicalTrials.gov

NCT05233956

Non-Device Trial