Tranexamic acid added to iron and vitamins for anaemia in menstruating women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 3 trial compares tranexamic acid 500 mg plus standard iron and vitamin supplementation to iron and vitamins alone for treating anaemia in adult women who are currently menstruating. Participants are eligible if they are 18 or older, have regular periods, and have anaemia confirmed by a finger-prick Hb test. The study aims to determine whether TXA can improve haemoglobin levels and reduce menstrual blood loss when used alongside standard care. The trial will be conducted at multiple international sites with in-person follow-up visits to monitor safety and effectiveness. Outcomes may inform future prescribing for managing anaemia in reproductive-age women.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.)

Where it's running

• University College Hospital
  Ibadan, Oyo State, Nigeria Recruiting
• Shifa Tameer e Millat University
  Islamabad, Pakistan Not yet recruiting
• Mbeya College of Health and Allied Sciences, University of Dar es Salaam
  Mbeya, Tanzania Not yet recruiting

Study contacts

• Principal investigator: Professor Ian Roberts — London School of Hygiene and Tropical Medicine (Clinical Trials Unit)
• Study coordinator: Eni Balogun
• Email: woman3@lshtm.ac.uk
• Phone: 020 7958 8117

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.