Status:
RECRUITING
Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya
Lead Sponsor:
FHI 360
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Anemia
Eligibility:
FEMALE
18-50 years
Phase:
NA
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 con...
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%...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05233956
Start Date
October 23 2023
End Date
July 31 2026
Last Update
April 20 2025
Active Locations (1)
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1
Kangemi Health Center
Nairobi, Kenya