AnaemiaPhase 3WOMAN-3NCT06519422
Tranexamic Acid for Anaemia Trial
A Phase 3 study testing Tranexamic Acid 500 MG in people with Anaemia, run by London School of Hygiene and Tropical Medicine at 3 sites in 3 countries.
Trial summary
Anaemia is when the body does not have enough healthy red blood cells to carry oxygen. It is common in women because they lose blood every month during their periods. Anaemia can womwn make feel tired, weak, dizzy and out of breath. It can also make it harder to study, work or look after their family. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anaemia
- What is being tested?
- Tranexamic Acid 500 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 10 Aug 2026to Sep 2028
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women aged 18 years and older.
- Currently menstruating, with menstrual periods occurring at least every 38 days and lasting ≥2 days.
- Anaemia at screening, defined as hemoglobin (Hb) <120 g/L by point-of-care finger prick test.
- Willing and able to provide informed consent.
- Able to attend in-person follow-up visits during the trial period.
- Individuals with known thalassaemia and sickle cell disease are eligible to participate and take the trial treatment but will not be given standard of care iron supplementation unless it is prescribed by their own treating clinician. They will continue to receive their usual standard care.
Who cannot join
- Planning to get pregnant during the trial period
- Already taking TXA
- Known to have possible contraindications to TXA treatment (including allergy to TXA or its excipients, renal impairment, active thromboembolic disease, history of venous or arterial thrombosis, history of convulsion.)
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Nigeria1 site, 1 recruiting
- Recruiting
University College Hospital
Ibadan, Oyo State
Folasade A Bello, +2347067427993, nigeria.woman3@lshtm-ctu.org
Folasade A Bello
Pakistan1 site, 1 recruiting
- Not yet recruiting
Shifa Tameer e Millat University
Islamabad
Rizwana Chaudhri, +923205514960, pakistan.woman3@lshtm-ctu.org
Rizwana Chaudhri
Tanzania1 site, 1 recruiting
- Not yet recruiting
Mbeya College of Health and Allied Sciences, University of Dar es Salaam
Mbeya
Projestine Muganyizi, +255688267218, tanzania.woman3@lshtm-ctu.org
Projestine Muganyizi
About this study
Official title: The Effects of Tranexamic Acid on Anaemia, Menstrual Health and the Wellbeing of Women: an International Randomised, Placebo-controlled Trial Among Menstruating Women With Anaemia
Anaemia is when the body does not have enough healthy red blood cells to carry oxygen. It is common in women because they lose blood every month during their periods. Anaemia can womwn make feel tired, weak, dizzy and out of breath. It can also make it harder to study, work or look after their family. If woman become pregnant with anaemia, it can cause problems for both mother and baby, such as early birth or heavy bleeding when giving birth. It is best to treat anaemia in young women well before they get pregnant. Doctors treat anaemia with iron and vitamins. But some people get side effects when taking iron tablets and so they stop taking them. Tranexamic acid (TXA) is a medicine used to treat heavy periods. The investigators of this study would like to find out if taking TXA with the usual iron and vitamin supplements is better at treating anaemia than taking iron and vitamin supplements alone. (Lay Summary)
Read the detailed description
World-wide, half a billion women of reproductive age are anaemic. Anaemia has major health consequences for pregnant women and their babies. Anaemia increases the risk of ante-partum haemorrhage, prematurity, stillbirth, neonatal death, post-partum haemorrhage and maternal death. Early intervention to reduce the risk of anaemia before pregnancy offers the potential to reduce adverse maternal and birth outcomes and improve well-being across the reproductive life course.
The global target, set in 2000, to halve the prevalence of anaemia in women of reproductive age by 2025 was not met. Anaemia worsens bleeding through multiple biological mechanisms. Anaemia increases blood flow from bleeding vessels due to reduced blood viscosity and anaemic blood clots are more susceptible to fibrinolysis. Although iron and multivitamin replacement is the mainstay of anaemia treatment, iron stores in young women depend more on menstrual iron loss than on dietary intake. Because anaemia worsens bleeding, women with anaemia have heavier menstrual periods than if they were not anaemic. For this reason, offering iron replacement without reducing menstrual iron loss may be inefficient.
The antifibrinolytic tranexamic acid (TXA) reduces menstrual bleeding by preventing blood clot breakdown. The investigators propose that giving TXA with iron and vitamin replacement will be more effective in treating anaemia than iron and vitamin replacement alone.
- Conditions
- Anaemia
- Being tested
- Tranexamic Acid 500 MG, Placebo
- Keywords
- Tranexamic acid, Antifibrinolytic, Anaemia, Menstrual health, Menstruation, Bleeding, Iron Deficiency
- Medical subject headings
- Anemia, Hemorrhage, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 500 MGDrug
Also called TXA, Tranexamic Acid
Tablets
PlaceboDrug
Also called Matched Placebo
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid (TXA) | Experimental | Tranexamic acid (TXA) 2 x 500 mg oral tablets, taken three times daily from the first to the last day of the menstrual period (maximum 5 days), for six consecutive menstrual cycles (up to a maximum of 9 months). Participants also receive standard of care oral iron and folic acid supplementation for three months from randomisation. Receives: Drug: Tranexamic Acid 500 MG |
| Placebo | Placebo comparator | Matching placebo 2 x 500 mg oral tablets, taken three times daily from the first to the last day of the menstrual period (maximum 5 days), for six consecutive menstrual cycles (up to a maximum of 9 months). Participants also receive standard of care oral iron and folic acid supplementation for three months from randomisation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Anaemia
Proportion of participants with hemoglobin (Hb) <120 g/L, measured via venous blood samples at baseline and at the end of the intervention period.
Measured: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Secondary outcomes (15)
Haemoglobin (Hb) concentration
Hb measured on venous blood at baseline and end of treatment/ early withdrawal
Measured: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Severity of anaemia
Mild Anaemia (Hb=110-119 g/L); Moderate Anaemia (Hb=80-109 g/L); Severe Anaemia (Hb < 80 g/L); Hb measured on venous blood
Measured: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Ferritin
Serum ferritin (from venous blood sample) and CRP-adjusted ferritin (see below, under C-reactive protein) measured at baseline and end of the intervention period; we will report change in iron status from baseline
Measured: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Iron deficiency
Iron deficiency defined as ferritin <15 ug/L (WHO definition) and defined as ferritin <30 ug/L, (new clinical consensus); Serum ferritin from venous blood sample; CRP-adjusted ferritin (see below, under C-reactive protein); we will report change in iron status from baseline
Note: CRP-adjusted ferritin (see below);
Measured: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
C-reactive protein (CRP)
Measured to adjust ferritin values. The Statistical Analysis Plan (SAP) will include details on how ferritin values will be corrected by taking into account CRP levels (inflammation marker), because normal ferritin concentrations may mask an iron deficient state if inflammation is present
Measured: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Iron-deficiency anaemia
The proportion of participants with iron-deficiency anaemia, defined as presence of both anaemia (Hb<120 g/L) plus iron deficiency (ferritin <15 ug/L AND/OR <30 ug/L)
Measured: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Menstrual blood loss
Self-reported number of menstrual products used
Measured: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Perceived change in menstrual blood loss
Participant's subjective assessment of intensity and impact of menstrual bleeding, using visual analogue scales (HMB-VAS), assessed at baseline and final visit
Measured: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Degree of effect of menstrual bleeding on health-related Quality of Life
SAMANTA scale (ref: Calaf, 2020, DOI: 10.1089/jwh.2018.7446 and Sinharoy 2023, DOI: 10.1016/S2214-109X(23)00416-3; Affirmative answers to two questions ('experiencing menstrual bleeding for >7 days per month' and 'being bothered by menstruation due to its Abundance') each receive 3 points, while affirmative answers to all other questions each receive 1 point ('≥3 days of heavier bleeding', 'blood spotting on clothes at night', 'worried about staining furniture', 'avoid some activities because of the need to change menstrual materials'). These values are summed, resulting in a potential range of values for the heavy menstrual bleeding score from 0 to 10.)
Measured: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Mean Menstrual Period Duration
Evaluated longitudinally via participant daily diary logs to assess changes in bleeding length across treatment cycles.
Measured: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Change From Baseline in Menstrual Pain Severity Score
Measured on a standard 0 to 10 numerical rating scale inside the participant diary, where 0 represents no pain and 10 represents the worst imaginable period pain.
Measured: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Mean Hemoglobin (Hb) Concentration at Final Visit
Analysed via laboratory venous blood collection to document efficacy on maternal anemia resolution.
Measured: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Mean Serum Ferritin Concentration at Final Visit
Evaluated via venous blood sample to track maternal iron storage status. Ferritin values will be adjusted against C-reactive protein levels within the final Statistical Analysis Plan (SAP) to prevent acute inflammation from masking underlying iron depletion.
Measured: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomisation).
Mean Systolic and Diastolic Blood Pressure at Study Completion
Monitored via a standard automated digital sphygmomanometer during in-person clinical visits.
Measured: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Mean Heart Rate at Study Completion
Pulse rates monitored on-site alongside vital sign collections.
Measured: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start10 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel design comparing tranexamic acid (TXA) versus placebo, with participants randomized in a 1:1 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dar es Salaam, Tanzania (Mbeya College of Health and Allied Sciences), Coefficient Giving, Versailles Saint-Quentin-en-Yvelines University, Shifa Tameer-e-Millat University, University College Hospital, Ibadan, The Jon Moulton Charity Trust, University of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Professor Ian Roberts, Principal investigator, London School of Hygiene and Tropical Medicine (Clinical Trials Unit)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519422
- Sponsor's protocol ID
- WOMAN-3
- Other IDs
- ISRCTN, PACTR
- Acronym
- WOMAN-3
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are committed to sharing data for ethical research with justified scientific objectives. Until all planned analyses are completed by the LSHTM CTU Global Health Trials Group, data will be shared through a controlled access approach; thereby researchers can make formal applications for data sharing. Afterwards, we will share the anonymised dataset via the LSHTM CTU Global Health Trials Group data sharing platform at freebird.lshtm.ac.uk or a similar platform. We will make all relevant trial materials available on the trial website.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tranexamic Acid on Anaemia, Menstrual Health and the Wellbeing of Women: an International Randomised, Placebo-controlled Trial Among Menstruating Women With Anaemia
- ClinicalTrials.gov ID
- NCT06519422
- Acronym / sponsor ID
- WOMAN-3 / WOMAN-3
- Conditions
- Anaemia
- Keywords
- Tranexamic acid, Antifibrinolytic, Anaemia, Menstrual health, Menstruation, Bleeding, Iron Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Dar es Salaam, Tanzania (Mbeya College of Health and Allied Sciences), Coefficient Giving, Versailles Saint-Quentin-en-Yvelines University, Shifa Tameer-e-Millat University, University College Hospital, Ibadan, The Jon Moulton Charity Trust, University of Edinburgh
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 25 Jul 2024 (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.
Anaemia is when the body does not have enough healthy red blood cells to carry oxygen. It is common in women because they lose blood every month during their periods. Anaemia can womwn make feel tired, weak, dizzy and out of breath. It can also make it harder to study, work or look after their family. If woman become pregnant with anaemia, it can cause problems for both mother and baby, such as early birth or heavy bleeding when giving birth. It is best to treat anaemia in young women well before they get pregnant. Doctors treat anaemia with iron and vitamins. But some people get side effects when taking iron tablets and so they stop taking them. Tranexamic acid (TXA) is a medicine used to treat heavy periods. The investigators of this study would like to find out if taking TXA with the usual iron and vitamin supplements is better at treating anaemia than taking iron and vitamin supplements alone. (Lay Summary)
Detailed description
World-wide, half a billion women of reproductive age are anaemic. Anaemia has major health consequences for pregnant women and their babies. Anaemia increases the risk of ante-partum haemorrhage, prematurity, stillbirth, neonatal death, post-partum haemorrhage and maternal death. Early intervention to reduce the risk of anaemia before pregnancy offers the potential to reduce adverse maternal and birth outcomes and improve well-being across the reproductive life course.
The global target, set in 2000, to halve the prevalence of anaemia in women of reproductive age by 2025 was not met. Anaemia worsens bleeding through multiple biological mechanisms. Anaemia increases blood flow from bleeding vessels due to reduced blood viscosity and anaemic blood clots are more susceptible to fibrinolysis. Although iron and multivitamin replacement is the mainstay of anaemia treatment, iron stores in young women depend more on menstrual iron loss than on dietary intake. Because anaemia worsens bleeding, women with anaemia have heavier menstrual periods than if they were not anaemic. For this reason, offering iron replacement without reducing menstrual iron loss may be inefficient.
The antifibrinolytic tranexamic acid (TXA) reduces menstrual bleeding by preventing blood clot breakdown. The investigators propose that giving TXA with iron and vitamin replacement will be more effective in treating anaemia than iron and vitamin replacement alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel design comparing tranexamic acid (TXA) versus placebo, with participants randomized in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid (TXA) | Experimental | Drug: Tranexamic Acid 500 MGTranexamic acid (TXA) 2 x 500 mg oral tablets, taken three times daily from the first to the last day of the menstrual period (maximum 5 days), for six consecutive menstrual cycles (up to a maximum of 9 months). Participants also receive standard of care oral iron and folic acid supplementation for three months from randomisation. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo 2 x 500 mg oral tablets, taken three times daily from the first to the last day of the menstrual period (maximum 5 days), for six consecutive menstrual cycles (up to a maximum of 9 months). Participants also receive standard of care oral iron and folic acid supplementation for three months from randomisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult women aged 18 years and older.
- Currently menstruating, with menstrual periods occurring at least every 38 days and lasting ≥2 days.
- Anaemia at screening, defined as hemoglobin (Hb) <120 g/L by point-of-care finger prick test.
- Willing and able to provide informed consent.
- Able to attend in-person follow-up visits during the trial period.
Key exclusion criteria (3 listed)
- Planning to get pregnant during the trial period
- Already taking TXA
- Known to have possible contraindications to TXA treatment (including allergy to TXA or its excipients, renal impairment, active thromboembolic disease, history of venous or arterial thrombosis, history of convulsion.)
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 |
|---|---|---|
| Tranexamic Acid 500 MGAlso: TXA, Tranexamic AcidTablets | Drug | Tranexamic acid (TXA) |
| PlaceboAlso: Matched PlaceboTablets | Drug | Placebo |
Primary outcome
Proportion of Participants with Anaemia
Time frame: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Proportion of participants with hemoglobin (Hb) <120 g/L, measured via venous blood samples at baseline and at the end of the intervention period.
15 secondary outcomes
Haemoglobin (Hb) concentration
Time frame: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Severity of anaemia
Time frame: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Ferritin
Time frame: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Iron deficiency
Time frame: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
C-reactive protein (CRP)
Time frame: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Iron-deficiency anaemia
Time frame: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.
Menstrual blood loss
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Perceived change in menstrual blood loss
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Degree of effect of menstrual bleeding on health-related Quality of Life
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Mean Menstrual Period Duration
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Change From Baseline in Menstrual Pain Severity Score
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Mean Hemoglobin (Hb) Concentration at Final Visit
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Mean Serum Ferritin Concentration at Final Visit
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomisation).
Mean Systolic and Diastolic Blood Pressure at Study Completion
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomization).
Mean Heart Rate at Study Completion
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomisation)
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 17 Aug 2026.
- Individual participant dataSharing planned: Yes. We are committed to sharing data for ethical research with justified scientific objectives. Until all planned analyses are completed by the LSHTM CTU Global Health Trials Group, data will be shared through a controlled access approach; thereby researchers can make formal applications for data sharing. Afterwards, we will share the anonymised dataset via the LSHTM CTU Global Health Trials Group data sharing platform at freebird.lshtm.ac.uk or a similar platform. We will make all relevant trial materials available on the trial website.
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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.
Professor Ian Roberts principal investigator
London School of Hygiene and Tropical Medicine (Clinical Trials Unit)
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid 500 MG in people with Anaemia, run by London School of Hygiene and Tropical Medicine at 3 sites in 3 countries.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nigeria, Pakistan, Tanzania. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Eni Balogun (020 7958 8117, woman3@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Anaemia (time frame: From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.). 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 17 Aug 2026.