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Birth control showdown: which method fights anemia better?

NCT ID NCT05233956

Disease control Sponsor: FHI 360 Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a hormonal IUS or birth control pills with iron are better at improving anemia in women. About 405 women with mild to moderate anemia who want contraception will be randomly assigned to one of the two methods and followed for 12-18 months. The main goal is to see which method raises hemoglobin levels more.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

405 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia

Contacts and locations

Locations

  • Kangemi Health Center

    Nairobi, Kenya

More trials for these conditions

Other studies related to the condition(s) this trial covers.