A Phase 3 interventional study of Tranexamic Acid 500 MG and Placebo in Anaemia, sponsored by London School of Hygiene and Tropical Medicine. Recruiting at 3 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by London School of Hygiene and Tropical Medicine · Phase 3, Interventional, and Treatment
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)
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →London School of Hygiene and Tropical Medicine is the lead sponsor of 298 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tranexamic Acid 500 MG
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.
Drug: Placebo
Tablets
Also known as: TXA, Tranexamic Acid
Tablets
Also known as: Matched Placebo
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.
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.
Haemoglobin (Hb) concentration
Hb measured on venous blood at baseline and end of treatment/ early withdrawal
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
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
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
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
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
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);
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)
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
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
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)
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
Self-reported number of menstrual products used
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
Participant's subjective assessment of intensity and impact of menstrual bleeding, using visual analogue scales (HMB-VAS), assessed at baseline and final visit
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
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.)
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
Evaluated longitudinally via participant daily diary logs to assess changes in bleeding length across treatment cycles.
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
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.
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
Analysed via laboratory venous blood collection to document efficacy on maternal anemia resolution.
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
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.
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
Monitored via a standard automated digital sphygmomanometer during in-person clinical visits.
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
Pulse rates monitored on-site alongside vital sign collections.
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomisation)
Cost-Effectiveness of Tranexamic Acid vs Placebo for Anemia Treatment
Evaluation of the cost-effectiveness of the trial interventions based on health-related unit costs calculated at the time of the analysis and clinical health outcomes (proportion of participants with anaemia resolved).
Time frame: At the time of analysis, following study completion
Participant Satisfaction With Primary IMP as Assessed by Likert Scale
Administered at the final clinical follow-up visit using a structured questionnaire question. Evaluation parameters rely on an explicit 5-point Likert scale layout: 1 = Very satisfied, 2 = Satisfied, 3 = Neutral, 4 = Dissatisfied, and 5 = Very dissatisfied. Lower numerical values signify superior levels of overall participant intervention satisfaction.
Time frame: At final visit (after 6th menstrual period or within 9 months from randomization).
Percentage of Participants Experiencing Pre-specified Adverse Events
Routine surveillance of systemic toxicities and safety outcomes detailed in the protocol, tracking the proportions of participants who develop nausea, vomiting, diarrhea, seizures, or thromboembolic events.
Time frame: From randomisation until 28 days following the final dose of the trial intervention.
Behavioral Treatment Adherence via Physical Tablet Counts
Measured quantitatively by counting remaining study tablets within returned treatment bottles at in-person follow-up contacts.
Time frame: Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomisation).
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Once all planned analyses are completed by the LSHTM CTU Global Health Trials Group following trial completion. Data will be shared indefinitely.
Access criteria: As described above
Data sharing details ↗ · freebird.lshtm.ac.uk
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tranexamic Acid
London School of Hygiene and Tropical Medicine →