One in three women with heavy menstrual bleeding will eventually need surgery because pills and hormonal coils fail or cause side effects. This trial tests whether a daily oral drug that temporarily induces a reversible menopausal state—then adds back low-dose hormones to prevent hot flushes and other side effects—can keep more women out of operating theatres. Current medical treatments for heavy menstrual bleeding stop working for many women within months, and surgery carries long waiting lists and ends future fertility. Relugolix-CT works at the brain level to shut down ovarian hormone production, then replaces just enough oestrogen and progestogen to control bleeding without the menopausal symptoms that made earlier versions of this approach impractical. If the drug proves more effective than standard care at improving quality of life over 12 months, and if the cost per quality-adjusted life year falls within NHS thresholds, the results could update NICE guidelines and give GPs a new first-line medical option. That would reduce surgical waiting lists, preserve fertility for women who want children, and offer a tablet alternative for those who cannot tolerate an intrauterine device.
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Research Question: What is the clinical and cost-effectiveness of Relugolix-CT compared with NICE recommended usual medical treatment in women with heavy menstrual bleeding (HMB)? Background: HMB affects one in three women with a major impact on lives. NICE initially recommends medical treatments such as the LNG-IUS or tablets (hormonal/non-hormonal) which act on the endometrium to reduce menstrual blood loss. Existing treatments have limited effectiveness and cause side effects. Over 50% of women on tablets and 10% using the LNG-IUS eventually seek surgery which is incompatible with future fertility and involves waiting lists of up to 2 years. Relugolix, a Gonadotropin Releasing Hormone receptor antagonist acts on the brain to block ovarian production of estradiol and progesterone creating a temporary (reversible) menopausal state. Addition of estradiol and norethisterone acetate to oral Relugolix (Relugolix-CT) ameliorates menopausal side effects, making this a viable treatment for women with HMB. Aim: To determine if Relugolix-CT is clinically and cost effective when compared to usual medical treatment in women with HMB? Objective: To compare Relugolix-CT with usual medical treatment in terms of the Menorrhagia Multi- Attribute Scale (MMAS) at 6 and 12 months. Methods: A two-arm multicentre superiority RCT with embedded process evaluation and cost-effectiveness analysis. Inclusion Criteria: Pre-menopausal women seeking treatment for HMB; fulfilling NICE criteria for medical management. Exclusion Criteria: Endometrial pre-cancer and cancer; intention to conceive within 12 months. NICE-endorsed contraindications to medical management for HMB. Intervention: Relugolix-CT: 40mg Relugolix, combined with estradiol 1mg, norethisterone acetate 0.5mg, orally once daily for 12 months. Comparator: Any NICE endorsed medical treatment for HMB, according to participant choice. Primary Outcome: The MMAS, a condition-specific patient reported QoL measured at 12 months. The primary economic outcome is the incremental cost per QALY gained with Relugolix-CT versus usual medical treatment from an NHS perspective over 12 months. Secondary Outcomes: The core outcome set for HMB including menstrual bleeding; cycle regularity, period duration, volume and frequency; generic QoL; participant rating of effect of treatment on HMB; plans for surgery; side-effects, serious adverse events and reactions; work productivity and impairment and cost to women. Patient questionnaires will be used to measure secondary outcomes at 6 and 12 months. Timelines for Delivery: Start date: 1 October 2025; Study duration: 42 months. Milestones: Prefunding: regulatory approvals; month 1-6 set-up, authorisations; Months 7-24: patient recruitment; Months 25-36: complete follow-up; Months 37-42: data analysis, interpretation of results, report writing and dissemination. Dissemination and Anticipated Impact: We will share trial findings with key stakeholders, including patients, PPI networks, healthcare professionals, NHS policymakers, and lay press. Dissemination will involve direct communication of the executive summary, links on professional society and charity websites, and articles in lay press. Executive summaries will be sent to Clinical Leads for Women’s Health in Integrated Care Systems, counterparts in the Devolved Nations, NICE, and the Royal Colleges (RCOG and RCGP). The results are expected to inform updates to NICE guidelines influencing UK practice.
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