Tranexamic Acid for Anaemia Trial

NCT06519422 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: WOMAN-3
• Study Type: interventional
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anaemia is a common health problem in women. It is often due to iron deficiency. Anaemia is a particular problem during pregnancy and is bad for the mother and baby. 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. Heavy menstrual periods are a common cause of iron deficiency and even if women do take iron, because they lose so much iron in their periods, they still become iron deficient. 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)

Conditions

Anemia

Keywords

Tranexamic acid; Antifibrinolytic; Anaemia; Menstrual health; Menstruation; Bleeding

Outcome Measures

Primary Outcomes (1)

• Anaemia

  The proportion of participants with anaemia, defined as Haemoglobin (Hb) \< 120 g/L (measured on venous blood)

  After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.

Secondary Outcomes (10)

• Haemoglobin (Hb) concentration

  After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.

• Severity of anaemia

  After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.

• Ferritin

  After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.

• Iron deficiency

  After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.

• C-reactive protein (CRP)

  After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.

Study Arms (2)

Tranexamic acid (TXA)

EXPERIMENTAL

Tranexamic acid 1 gram (2x 500 mg) orally taken three times a day from the first to the last day of the menstrual period for up to 5 days, for 3 successive periods.

Drug: Tranexamic Acid 500 MG

Placebo

PLACEBO COMPARATOR

Matched placebo tablets taken three times a day from the first to the last day of the menstrual period for up to 5 days, for 3 successive periods.

Other: Matched placebo

Interventions

Tranexamic Acid 500 MG DRUG

Tablets

Tranexamic acid (TXA)

Matched placebo OTHER

Matched placebo tablets (inactive ingredients only, including microcrystalline cellulose, magnesium stearate BP and lactose)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women (aged 18 years and older)
• Having menstrual periods every 21 to 38 days that last 2 to 9 days
• Having anaemia (Hb \< 120 g/L) according to point-of-care finger prick screening test
• Willing to provide informed consent and able to attend study visits during the trial period
• (Individuals with known thalassaemia are eligible to participate and take the trial treatment but will not receive standard of care iron supplementation. They will continue to receive their standard care.)

You may not qualify if:

• Planning to get pregnant during trial period
• Already taking TXA
• Known to have 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.)

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• The Jon Moulton Charity Trust: collaborator

MeSH Terms

Conditions

Anemia; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Dr Sima Berendes

  London School of Hygiene and Tropical Medicine (Clinical Trials Unit)

  STUDY DIRECTOR

Central Study Contacts

Dr Sima Berendes

CONTACT

+44 (0)20 7958 8161; woman3@lshtm.ac.uk

Professor Ian Roberts

CONTACT

+44 (0)20 7958 8128

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 25, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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