Low dose dexamethasone as treatment for women with heavy menstrual bleeding: A response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM)

Pamela Warner, Lucy Whitaker, Richard Parker, Christopher J. Weir, Anne Douglas, Christian Holm Hansen, Mayank Madhra, Stephen G. Hillier, Philippa T. K. Saunders, John P. Iredale, Scott Semple, Ov D. Slayden, Brian R. Walker, Hilary Critchley
In: eBioMedicine · 2021 · vol. 69 , pp. 103434 · doi:10.1016/j.ebiom.2021.103434 · W4232684864
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⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

This adaptive randomized trial found that 18 mg daily dexamethasone reduced menstrual blood loss by 25 mL compared to placebo in women with heavy menstrual bleeding.

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Abstract

Background: The symptom of heavy menstrual bleeding (HMB) diminishes quality-of-life for many mid-age women and imposes substantial societal burden. We investigated our hypothesis that HMB reflects impaired endometrial vasoconstriction due to endometrial glucocorticoid deficiency. Does reversing this deficiency, by short-term luteal-phase treatment with exogenous glucocorticoid (dexamethasone), ameliorate HMB? Methods: In our Bayesian response-adaptive parallel-group placebo-controlled randomised trial, five preplanned interim analyses used primary outcome data to adjust randomisation probabilities to favour doses providing most dose-response information. Participants with HMB, recruited from Lothian (Scotland) NHS clinics and via community invitations/advertisements, were aged over 18 years; reported regular 2142 day menstrual cycles; and had measured menstrual blood loss (MBL) averaging 50 mL over two screening periods. Identically encapsulated placebo, or one of six Dexamethasone doses (02 mg, 04 mg, 05 mg, 06 mg, 075 mg, 09 mg), were taken orally twice-daily over five days in the mid-luteal phase of three menstrual cycles. Participants, investigators, and those measuring outcomes were masked to group assignment. Primary outcome, change in average MBL from screening to 'treatment', was analysed by allocated treatment, for all with data. Trial Registration: ClinicalTrials.gov NCT01769820; EudractCT 2012003,40598 Findings: Recruitment lasted 29/01/2014 to 25/09/2017; 176 were screened, 107 randomised and 97 provided primary outcome data (n = 24,5,9,21,8,14,16 in the seven arms, placebo to 18 mg total daily active dose). In Bayesian normal dynamic linear modelling, 18 mg dexamethasone daily showed a 25 mL greater reduction in MBL from screening, than placebo (95% credible interval 1 to 49 mL), and probability 098 of benefit over placebo. Adverse events were reported by 75% (58/77) receiving dexamethasone, 58% (15/26) taking placebo. Three serious adverse events occurred, two during screening, one in a placebo participant. No woman withdrew due to adverse effects. Interpretation: Our adaptive trial in HMB showed that dexamethasone 18 mg daily reduced menstrual blood loss. The role of dexamethasone in HMB management deserves further investigation.

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