Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya
LISA
2 other identifiers
interventional
600
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2022
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedStudy Start
First participant enrolled
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
April 20, 2025
April 1, 2025
2.8 years
January 7, 2022
April 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in hemoglobin
Measured in g/L
18 months
Secondary Outcomes (4)
Change in serum ferritin
18 months
Change in number of days of bleeding/spotting in a month
18 months
Contraceptive method discontinuation
18 months
Contraceptive satisfaction
18 months
Study Arms (2)
LNG IUS
EXPERIMENTALLevonorgestrel intrauterine system
COC
ACTIVE COMPARATORCombined oral contraceptives with ferrous fumarate tablets in regimen
Interventions
Avibela®: Levonorgestrel intrauterine system (LNG IUS) containing 52mg of LNG, released in the uterine cavity at approximately 19mcg per day.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kangemi Health Center
Nairobi, Kenya
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Hubacher, PhD
FHI 360
- PRINCIPAL INVESTIGATOR
Faith Thuita, PhD
University of Nairobi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2022
First Posted
February 10, 2022
Study Start
October 23, 2023
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
April 20, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- Deidentified quantitative research data will be made available in a timely manner once the main findings from the research have been accepted for publication.
- Access Criteria
- Data generated under the project will be shared consistent with the NIH Grant Policy, the USAID ADS 579, and the FHI 360 Protection of Human Subjects (PHSC) committee guidelines. Data will be de-identified to avoid linkages to individual research participants and will be free of variables that could lead to deductive disclosure of the identity of individual research participants. A de-identified primary dataset will be posted to an open-data repository within 30 calendar days after the first publication.
Data generated under the project will be shared consistent with the NIH Grant Policy, the USAID ADS 579, and the FHI 360 Protection of Human Subjects (PHSC) committee guidelines. Data will be de-identified to avoid linkages to individual research participants and will be free of variables that could lead to deductive disclosure of the identity of individual research participants. A de-identified primary dataset will be posted to an open-data repository within 30 calendar days after the first publication.