Effects of a contraceptive device on anemia in 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
This study is testing if a contraceptive device can help women in Kenya with mild to moderate anemia have better hemoglobin levels compared to taking the pill.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Fhi 360 Academic / other |
| Locations | 1 site (Nairobi) |
| Trial ID | NCT05233956 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of the levonorgestrel intrauterine system (LNG IUS) on hemoglobin levels and serum ferritin in women with mild to moderate anemia who are seeking contraception. Participants will be randomly assigned to receive either the LNG IUS or a combined oral contraceptive regimen for 18 months. The study aims to determine if the LNG IUS can significantly improve hemoglobin concentrations compared to traditional oral contraceptives, addressing a critical health issue in resource-poor settings. Approximately 600 women will be enrolled, and their health outcomes will be monitored over the study period.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-50 with mild to moderate anemia who desire contraception.
Not a fit: Patients with severe anemia or those currently pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new contraceptive option that also improves anemia in women, enhancing their overall health and quality of life.
How similar studies have performed: Previous research has shown that the LNG IUS can improve hemoglobin levels in women with heavy menstrual bleeding, but this specific application in anemic women is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Nairobi
- Kangemi Health Center — Nairobi, Kenya (Recruiting)
Study contacts
- Principal investigator: David Hubacher, PhD — Fhi 360
- Study coordinator: David Hubacher, PhD
- Email: dhubacher@fhi360.org
- Phone: 9195447040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.