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Low-dose dexamethasone as a treatment for women with heavy menstrual bleeding: protocol for response-adaptive
P Warner1, C J Weir2, C H Hansen3
1Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
Insights
This study investigated if dexamethasone can reduce heavy menstrual bleeding (HMB) by addressing endometrial glucocorticoid deficiency. Results from the DexFEM trial will determine the optimal dose for treating HMB.
Area of Science:
- Reproductive endocrinology
- Gynecology
- Clinical pharmacology
Background:
- Heavy menstrual bleeding (HMB) significantly impacts quality of life and incurs societal costs.
- Endometrial glucocorticoid deficiency, potentially caused by cortisol inactivation via 11β-hydroxysteroid dehydrogenase type 2 (11βHSD2), may contribute to HMB by increasing angiogenesis and impairing vasoconstriction.
- Restoring luteal phase endometrial glucocorticoid levels is hypothesized to reduce menstrual bleeding.
Purpose of the Study:
- To evaluate the efficacy of dexamethasone in reducing menstrual blood loss (MBL) in women with HMB.
- To determine the optimal dose of dexamethasone for treating HMB.
- To assess the treatment effect and acceptability of dexamethasone compared to placebo.
Main Methods:
- A double-blind, response-adaptive, parallel-group, placebo-controlled trial (DexFEM) involving 108 women with HMB (mean MBL ≥50 mL).
- Participants received oral dexamethasone (a synthetic glucocorticoid resistant to 11βHSD2 inactivation) or placebo for 5 days during the mid-luteal phase of three cycles.
- Six low doses of dexamethasone (0.2–0.9 mg twice daily) were compared against placebo, with dose-response optimization using Bayesian Normal Dynamic Linear Modelling.
Main Results:
- The primary outcome was the reduction in MBL from screening levels.
- Secondary outcomes included questionnaire-based assessments of treatment effect and acceptability.
- Bayesian modeling was used to identify the optimal dexamethasone dose for reducing MBL, with 95% credible intervals calculated for effects versus placebo.
Conclusions:
- The study aims to establish whether dexamethasone can effectively reduce heavy menstrual bleeding.
- Identifying an optimal, safe, and effective dose of dexamethasone could offer a novel therapeutic strategy for HMB.
- Findings will be disseminated through open-access publications and conferences to inform clinical practice.
Introduction:
Heavy menstrual bleeding (HMB) diminishes individual quality-of-life and poses substantial societal burden. In HMB endometrium, inactivation of cortisol (by enzyme 11β hydroxysteroid dehydrogenase type 2 (11βHSD2)), may cause local endometrial glucocorticoid deficiency and hence increased angiogenesis and impaired vasoconstriction. We propose that 'rescue' of luteal phase endometrial glucocorticoid deficiency could reduce menstrual bleeding.
Methods And Analysis:
DexFEM is a double-blind response-adaptive parallel-group placebo-controlled trial in women with HMB (108 to be randomised), with active treatment the potent oral synthetic glucocorticoid dexamethasone, which is relatively resistant to 11βHSD2 inactivation. Participants will be aged over 18 years, with mean measured menstrual blood loss (MBL) for two screening cycles ≥50 mL. The primary outcome is reduction in MBL from screening. Secondary end points are questionnaire assessments of treatment effect and acceptability. Treatment will be for 5 days in the mid-luteal phases of three treatment menstrual cycles. Six doses of low-dose dexamethasone (ranging from 0.2 to 0.9 mg twice daily) will be compared with placebo, to ascertain optimal dose, and whether this has advantage over placebo. Statistical efficiency is maximised by allowing randomisation probabilities to 'adapt' at five points during enrolment phase, based on the response data available so far, to favour doses expected to provide greatest additional information on the dose-response. Bayesian Normal Dynamic Linear Modelling, with baseline MBL included as covariate, will determine optimal dose (re reduction in MBL). Secondary end points will be analysed using generalised dynamic linear models. For each dose for all end points, a 95% credible interval will be calculated for effect versus placebo.
Ethics And Dissemination:
Dexamethasone is widely used and hence well-characterised safety-wise. Ethical approval has been obtained from Scotland A Research Ethics Committee (12/SS/0147). Trial findings will be disseminated via open-access peer-reviewed publications, conferences, clinical networks, public lectures, and our websites.
Trial Registration Number:
ClinicalTrials.gov NCT01769820; EudractCT 2012-003405-98.
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