Lukes 2010.

Methods	Multi‐centre (40 clinical sites), double‐blind, parallel‐group study Randomization via permuted block randomization scheme, with a block size of 8 (5 allocated to intervention arm, and 3 to placebo arm) Blinding: participants, investigators, sponsor, statisticians, clinical data management staff, and clinical monitors were all blinded Duration of trial: 2 control cycles pre‐treatment; 6 cycles of treatment
Participants	Country: USA Age: 18 to 49 years old Number of participants: 196 women randomized Inclusion criteria: history of at least 3 days of HMB over at least 4 of their last 6 cycles; confirmed during 2 cycles before treatment phase commenced; normal pelvic examination and Pap smear; no "clinically important" findings on transvaginal ultrasound; willingness to use non‐hormonal contraception during the trial Exclusion criteria: history of significant medical problem; severe anaemia (Hb < 8 g/dL); pregnant/lactating; endometrial abnormalities; cervical carcinoma; anovulatory dysfunctional uterine bleeding; glaucoma; ocular hypertension; use of anticoagulants; aspirin; dong quai; aminocaproic acid; hydroxychloroquine Note: uterine fibroids were only an exclusion criteria if thought to require surgical management
Interventions	TXA 1.3 g 3 times daily (123 participants), commenced with the onset of HMB, for up to 5 days versus placebo (73 participants) 3 times daily, commenced with the onset of HMB, for up to 5 days
Outcomes	Objective measurement of MBL: alkaline haematin method (change scores) Subjective improvements in MBL: MIQ; occurrence of large blood stains Hb and ferritin concentrations Side effects
Notes	11 of 12 authors report receiving funding from 1 (or more) drug company/companies
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Permuted block randomization schedule
Allocation concealment (selection bias)	Low risk	Allocation managed by an independent group ("Fisher Clinical Services")
Blinding (performance bias and detection bias) All outcomes	Low risk	Participants, investigators and assessors were all blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	28% participants (55/196) withdrew, but proportions were similar in each study arm, and 95% were included in a modified intention‐to‐treat analysis
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes reported
Other bias	Unclear risk	Imbalances between groups in baseline MBL