# Clinical trial with the levonorgestrel intrauterine system to measure changes in hemoglobin and serum ferritin among anemic women in Kenya

> **NIH NIH R01** · FAMILY HEALTH INTERNATIONAL · 2020 · $536,317

## Abstract

PROJECT SUMMARY/ABSTRACT
 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, which are widely available and used in Kenya. 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.

## Key facts

- **NIH application ID:** 10050175
- **Project number:** 1R01HD100497-01A1
- **Recipient organization:** FAMILY HEALTH INTERNATIONAL
- **Principal Investigator:** DAVID HUBACHER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $536,317
- **Award type:** 1
- **Project period:** 2020-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10050175

## Citation

> US National Institutes of Health, RePORTER application 10050175, Clinical trial with the levonorgestrel intrauterine system to measure changes in hemoglobin and serum ferritin among anemic women in Kenya (1R01HD100497-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10050175. Licensed CC0.

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