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

NCT ID: NCT05233956

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2026-07-31

Brief 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

Detailed Description

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.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LNG IUS

Levonorgestrel intrauterine system

Group Type: EXPERIMENTAL

LNG IUS

Intervention Type: DEVICE

Avibela®: Levonorgestrel intrauterine system (LNG IUS) containing 52mg of LNG, released in the uterine cavity at approximately 19mcg per day.

COC

Combined oral contraceptives with ferrous fumarate tablets in regimen

Group Type: ACTIVE_COMPARATOR

COCs

Intervention Type: DRUG

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).

Interventions

LNG IUS

Avibela®: Levonorgestrel intrauterine system (LNG IUS) containing 52mg of LNG, released in the uterine cavity at approximately 19mcg per day.

Intervention Type: DEVICE

COCs

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provide sequential oral and written consents to screen for eligibility and enroll
• Female, aged 18-50
• Desire to use contraception or possibly switch methods
• Possession of a cell phone and willingness to be contacted
• Confirmatory low hemoglobin (minimum of 87 g/L and maximum of 126 g/L) taken 1 to 4 weeks after the initial test
• Regularly menstruating (at least once every 35 days)
• At least 6 weeks postpartum
• Willingness to agree to study procedures
• Willingness to be randomized to treatment
• Willingness to use assigned hormonal contraceptive for 18 months

Exclusion Criteria

• Severe anemia (hemoglobin < 86 g/L)
• Currently pregnant based on urine pregnancy test and failure to rule out possible pregnancy according to WHO guidelines
• Surgically sterilized or had a hysterectomy
• Participated previously in this study by being randomized to contraceptive
• Currently using a subdermal contraceptive implant and does not wish to have it removed
• Currently using an LNG IUS
• Currently receiving treatment for anemia
• Any of the following previously diagnosed disorders: hemosiderosis, hemochromatosis, hemolytic anemia
• Known allergic reactions to oral contraceptives or LNG IUS
• Currently receiving an investigational (unapproved) drug in another study
• Any condition (social or medical) which in the opinion of the investigator would make study participation unsafe
• Intending to become pregnant in the next 18 months
• Mucopurulent cervicitis
• Pelvic inflammatory disease
• Other medical contraindications to treatment, according to WHO Medical Eligibility Criteria (categories 3 or 4)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

FHI 360

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Hubacher, PhD

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Faith Thuita, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nairobi

Locations

Kangemi Health Center

Nairobi, , Kenya

Site Status: RECRUITING

Countries

Kenya

Central Contacts

David Hubacher, PhD

Role: CONTACT

dhubacher@fhi360.org

9195447040

Laura Frye

Role: CONTACT

LFrye@fhi360.org

Facility Contacts

Faith Thuita, Ph.D

Role: primary

fthuita@uonbi.ac.ke

Other Identifiers

R01HD100497

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1712233

Identifier Type: -

Identifier Source: org_study_id