Tranexamic Acid to Increase Quality of Life and Haemoglobin Levels in Bangladeshi Adolescent Girls

A Randomised, Double-Blind, Placebo-Controlled Trial Evaluating the Effectiveness of Tranexamic Acid in Improving Quality of Life and Haemoglobin Levels Among Adolescent Girls with Heavy Menstrual Bleeding in Bangladesh

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12626001013358

Acronym

TAQLABA

Enrollment

1000

Registered

2026-08-17

Start date

2026-10-30

Completion date

2028-03-31

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Heavy menstrual bleeding (HMB) causes significant iron loss, leading to iron deficiency anaemia. This leads to fatigue, poor learning, and risks during future pregnancies. Almost half of Bangladeshi adolescent girls are affected, while no standard HMB care is implemented for this group. Tranexamic acid (TXA), an effective non-hormonal treatment, could be a suitable solution, as shown in several small, short-term randomized controlled trials (RCTs) in high-income countries. This trial aims to provide evidence for TXA use in this low- and middle- income country setting, like Bangladesh.

Interventions

International Non-proprietary Name (INN): Tranexamic Acid Dose: 2 x 500mg tablets taken three times daily (3.0g/day total) Duration of treatment: Twelve months (treatment taken on the first day of menstruation and continuing for up to four days or until bleeding stops, whichever occurs first) Mode of delivery: Oral tablet Adherence: scheduled visits (at 3, 6, 9, and 12 months post-randomization) and monthly home visits

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

15 Years to 17 Years

Healthy volunteers

Inclusion criteria

(1) 15 to 17 years of age at the time of screening. (2) Unmarried. (3) Attending school and expected to remain in school for the next 12 months. (4) Self-reported heavy menstrual bleeding as detected by a score on the SAMANTA questionnaire tool of >= 3. (5) Residing in the study catchment area and expected to remain in the study setting for the next 12 months. (6) Agree to provide consent (assent) to participate in the study.

Exclusion criteria

(1) Current use of hormonal contraceptives. (2) Current use of iron supplementation. (3) Married or expecting marriage in the next 12 months. (4) Known history of thrombosis. (5) Known history of problem with colour vision. (6) Known sensitivity to tranexamic acid (TXA). (7) Current participant in any other intervention trial.

Outcome results