AnemiaLISANCT05233956
Levonorgestrel Intrauterine System Effects on Hemoglobin and Serum Ferritin Among Anemic Women in Kenya
A study testing LNG IUS and COCs in people with Anemia, run by FHI 360 at 1 site in Kenya.
Trial 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 12-18 months. Approximately 400 participants will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- LNG IUS and COCs
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteKenya
- Study dates
- 23 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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 12-18 months. Approximately 400 participants will be enrolled. The primary hypothesis that the mean change in hemoglobin in the group assigned to the LNG IUS will be superior to the COC/ferrous fumarate (control) group after 12-months of product use.
Read the 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
- Being tested
- LNG IUS, COCs
- Keywords
- hormonal contraception, intrauterine system, hemoglobin, anemia, oral contraceptives
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNG IUSDevice
Avibela®: Levonorgestrel intrauterine system (LNG IUS) containing 52mg of LNG, released in the uterine cavity at approximately 19mcg per day.
COCsDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| LNG IUS | Experimental | Levonorgestrel intrauterine system Receives: Device: LNG IUS |
| COC | Active comparator | Combined oral contraceptives with ferrous fumarate tablets in regimen Receives: Drug: COCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Level
Measured in g/L
Measured: 12 months
Secondary outcomes (5)
Serum ferritin Level
Measured in mcg/L
Measured: 18 months
Volume of menstrual blood loss and quantity of hygiene products used
Self-report
Measured: 3, 6, 9, 12, 15, and 18 months
Severe Anemia
Venous hemoglobin less than 86g/L
Measured: At 6,12 and 18 months
Contraceptive satisfaction
Level of satisfaction with the products will be recorded on a 5-point Likert scale: very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied.
Measured: 12-18 months
Hemoglobin Changes
g/L
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start23 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- David Hubacher, PhD, Principal investigator, FHI 360Faith Thuita, PhD, Principal investigator, University of Nairobi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233956
- Sponsor's protocol ID
- 1712233
- Other IDs
- R01HD100497
- Acronym
- LISA
- Status last verified
- Mar 2026
- First submitted
- 7 Jan 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated under the project will be shared consistent with the NIH Grant Policy, 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05233956
- Acronym / sponsor ID
- LISA / 1712233
- Conditions
- Anemia
- Keywords
- hormonal contraception, intrauterine system, hemoglobin, anemia, oral contraceptives
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 405 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 12-18 months. Approximately 400 participants will be enrolled. The primary hypothesis that the mean change in hemoglobin in the group assigned to the LNG IUS will be superior to the COC/ferrous fumarate (control) group after 12-months of product use.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNG IUS | Experimental | Device: LNG IUSLevonorgestrel intrauterine system |
| COC | Active comparator | Drug: COCsCombined oral contraceptives with ferrous fumarate tablets in regimen |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNG IUSAvibela®: Levonorgestrel intrauterine system (LNG IUS) containing 52mg of LNG, released in the uterine cavity at approximately 19mcg per day. | Device | LNG IUS |
| COCsFemiplanTM: 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). | Drug | COC |
Primary outcome
Hemoglobin Level
Time frame: 12 months
Measured in g/L
5 secondary outcomes
Serum ferritin Level
Time frame: 18 months
Volume of menstrual blood loss and quantity of hygiene products used
Time frame: 3, 6, 9, 12, 15, and 18 months
Severe Anemia
Time frame: At 6,12 and 18 months
Contraceptive satisfaction
Time frame: 12-18 months
Hemoglobin Changes
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Yes. Data generated under the project will be shared consistent with the NIH Grant Policy, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hubacher, PhD principal investigator
FHI 360
Faith Thuita, PhD principal investigator
University of Nairobi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LNG IUS and COCs in people with Anemia, run by FHI 360 at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin Level (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.